Automated External Defibrillators (Non-Wearable)
FDA product code MKJ · Class III (high risk) · 21 CFR 870.5310 · Cardiovascular
This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally. The device can be sold with prescription only.
228510(k) clearances
17PMA approvals
295recalls
Manufacturers
- ZOLL Medical Corporation 35
- Physio-Control Corp. 18
- Zoll Medical Corporation, World Wide Headquarters 17
- Philips Medical Systems 17
- Cardiac Science Corporation 17
- Bio-Detek, Inc. 10
- Medtronic Physio-Control Corp. 7
- Defibtech, LLC 7
- Katecho, Inc. 7
- Medical Research Laboratories, Inc. 7
- Survivalink Corp. 6
- Hewlett-Packard Co. 6
- Graphic Controls Corp. 6
- HeartSine Technologies Ltd 6
- Medtronic Emergency Response Systems, Inc. 5
- Leonhard Lang GmbH 5
- Padpro, LLC 5
- Amco International Manufacturing & Design, Inc. 4
- Marquette Electronics, Inc. 4
- Agilent Technologies, Inc. 4
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143714 | Powerheart G5 AEDMKJ · Traditional | Cardiac Science Corporation | 05/04/2015SE |
| K150198 | CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz GelMKJ · Traditional | Bio-Detek, Inc. | 05/02/2015SE |
| K150055 | OneStep Pediatric CPR Multi-Function ElectrodeMKJ · Traditional | Bio-Detek, Inc. | 05/02/2015SE |
| K142709 | samaritan PAD 450PMKJ · Traditional | Heartsine Technologies, Inc. | 03/27/2015SE |
| K133659 | Heartstart Xl+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringMKJ · Traditional | Philips Medical Systems | 01/23/2015SE |
| K133239 | Zoll E SeriesMKJ · Traditional | Zoll Medical Corporation, World Wide Headquarters | 01/16/2015SE |
| K142430 | LIFEPAK 15 monitor/defibrillatorMKJ · Traditional | Physio-Control, Inc. | 12/19/2014SE |
| K141795 | Batter Pack, Replacement for Physio Control Lifepak 500MKJ · Traditional | R & D Batteries, Inc. | 12/08/2014SE |
| K142915 | ZOLL X SeriesMKJ · Traditional | ZOLL Medical Corporation | 12/03/2014SE |
| K142803 | Skintact, various other tradenamesMKJ · Traditional | Leonhard Lang GmbH | 12/02/2014SE |
| K141231 | ZP9141, ZP9146Y, ZP9146W Non-Rechargeable BatteryMKJ · Traditional | Zeller Power Products (Battery Beast, LLC) | 11/25/2014SE |
| K141774 | Zoll X SeriesMKJ · Traditional | ZOLL Medical Corporation | 11/19/2014SE |
| K133441 | Onestep CPR II Multi-Function ElectrodeMKJ · Traditional | Bio-Detek, Inc. | 10/10/2014SE |
| K133484 | Zoll X SeriesMKJ · Traditional | Zoll Medical Corp | 08/01/2014SE |
| K133269 | Zoll X SeriesMKJ · Traditional | Zoll Medical Corporation, World Wide Headquarters | 05/22/2014SE |
| K131525 | Semiautomatic External Defibrillator and AccessoriesMKJ · Traditional | Defibtech, LLC | 04/24/2014SE |
| K122758 | Powerheart G5 AEDMKJ · Traditional | Cardiac Science Corporation | 02/12/2014SE |
| K131550 | Heart SyncMKJ · Traditional | Heart Sync, Inc. | 12/06/2013SE |
| K130684 | Philips Heartstart FR3 Automated External DefibrillatorMKJ · Traditional | Philips Medical Systems | 10/18/2013SE |
| K131494 | Heart SyncMKJ · Traditional | Heart Sync, Inc. | 09/16/2013SE |
| K130454 | Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/MonitorMKJ · Traditional | Physio-Control, Inc. | 08/21/2013SE |
| K123881 | Heartsine Samaritan Pad 350PMKJ · Traditional | Heartsine Technologies, Inc. | 07/11/2013SE |
| K130153 | Hearstart MRX with Airway Confimration AssistMKJ · Traditional | Philips Medical Systems | 03/12/2013SE |
| K113787 | DDU-120 Fully Automatic External Defibrillator and AccessoriesMKJ · Traditional | Defibtech, LLC | 01/04/2013SE |
| K122839 | Zoll Surepower Single Bay ChargerMKJ · Special | ZOLL Medical Corporation | 12/13/2012SE |
| K121853 | DDU-2400/2450 Semiautomatic External Defibrillator and AccessoriesMKJ · Traditional | Defibtech, LLC | 12/13/2012SE |
| K120350 | Extended Life BatteryMKJ · Traditional | Aed Battery Exchange, LLC | 11/01/2012SE |
| K120406 | Zoll Fully Automatic AED PlusMKJ · Traditional | Zoll Medical Corporation, World Wide Headquarters | 10/26/2012SE |
| K122600 | Lifepak 1000 DefibrillatorMKJ · Traditional | Physio-Control, Inc. | 10/11/2012SE |
| K120907 | Zoll R SeriesMKJ · Traditional | Zoll Medical Corporation, World Wide Headquarters | 09/25/2012SE |
| K120536 | Heart Sync Pediatric Physio AED PadMKJ · Traditional | Heart Sync, Inc. | 08/06/2012SE |
| K112761 | Zoll Propaq MDMKJ · Traditional | Zoll Medical Corporation, World Wide Headquarters | 04/25/2012SE |
| K112432 | Zoll X SeriesMKJ · Traditional | Zoll Medical Corporation, World Wide Headquarters | 03/21/2012SE |
| K110825 | Philips Heartstart Xl+, Philips Heartstart External Paddles, Philips Multifunction…MKJ · Traditional | Philips Medical Systems | 02/16/2012SE |
| K111693 | Philips Heartstart FR3 Automated External DefibrillatorMKJ · Traditional | Philips Medical Systems | 10/28/2011SE |
| K111594 | Zoll E SeriesMKJ · Traditional | Zoll Medical Corporation, World Wide Headquarters | 08/17/2011SE |
| K102496 | Powerheart AED G3 Semi-Automatic, Powerheart AED G3 Automatic, Powerheart AED G3 Pro…MKJ · Special | Cardiac Science Corporation | 06/09/2011SE |
| K110978 | Onestep Pediatric Mfe'sMKJ · Abbreviated | ZOLL Medical Corporation | 05/13/2011SE |
| K110742 | Onestep Adult Multi-Function ElectrodeMKJ · Special | ZOLL Medical Corporation | 04/13/2011SE |
| K110526 | Zoll Aedpro with 2010 Aha Guidelines Software UpdateMKJ · Special | ZOLL Medical Corporation | 03/25/2011SE |
| K103567 | Lifepak 15 Monitor/DefibrillatorMKJ · Traditional | Physio-Control, Inc. | 03/22/2011SE |
| K110361 | Zoll R Series with 2010 Aha Guidelines Software UpdateMKJ · Special | Zoll Medical Corporation, World Wide Headquarters | 03/08/2011SE |
| K110168 | Zoll E Series with 2010 Aha Guidlines Software UpdateMKJ · Special | Zoll Medical Corporation, World Wide Headquarters | 02/17/2011SE |
| K110154 | Zoll AED Plus with 2010 Aha Guidlines Software UpdateMKJ · Special | Zoll Medical Corporation, World Wide Headquarters | 02/17/2011SE |
| K103186 | Skintact Radiotransparent Multifunction ElectrodesMKJ · Traditional | Leonhard Lang GmbH | 02/08/2011SE |
| K102972 | Lifepak 12MKJ · Special | Physio-Control, Inc. | 12/22/2010SE |
| K100565 | Dura Padz (Reusable Electrode), Dura Padz Gel (Disposable Hydrogel) Model 8900-0300…MKJ · Traditional | Bio-Detek, Inc. | 11/16/2010SE |
| K091561 | Zoll AED Plus Version 5.32 Software ReleaseMKJ · Traditional | ZOLL Medical Corporation | 09/23/2010SE |
| K092391 | Mobileaed, Mobileals, Mobileaed+ and AdvantageaedMKJ · Traditional | Concord Medical Products | 04/01/2010SE |
| K091265 | Zoll E Series with CprreadychargeMKJ · Traditional | Zoll Medical Corporation, World Wide Headquarters | 12/23/2009SE |
| K092598 | Zoll E Series with Spco/Spmet OptionMKJ · Traditional | Zoll Medical Corporation, World Wide Headquarters | 12/03/2009SE |
| K090989 | Zoll R Series with Nibp and ETCO2 Options, Zoll R SeriesMKJ · Traditional | Zoll Medical Corp | 09/23/2009SE |
| K091943 | Powerheart AED G3, Model 9390E, Powerheart AED G3 Automatic, Model 9390AMKJ · Special | Cardiac Science Corporation | 09/10/2009SE |
| K091548 | Amco Replacement Battery for Philips Medical Models BT1 and M5070AMKJ · Traditional | Amco International Manufacturing & Design, Inc. | 08/07/2009SE |
| K081259 | DDU-2300 Semiautomatic External Defibrillator and AccessoriesMKJ · Traditional | Defibtech, LLC | 06/15/2009SE |
| K082937 | Lifepak 15 Monitor/DefibrillatorMKJ · Traditional | Physio-Control, Inc. | 03/11/2009SE |
| K081081 | Zoll E Series with Bluetooth Dial Up NetworkingMKJ · Traditional | Zoll Medical Corporation, World Wide Headquarters | 03/09/2009SE |
| K082090 | 9131 Defibrillation ElectrodesMKJ · Special | Cardiac Science Corporation | 12/12/2008SE |
| K081828 | Zoll R Series BLS DefibrillatorMKJ · Traditional | ZOLL Medical Corporation | 12/09/2008SE |
| K080903 | Zoll E Series with Intibation Assist OptionMKJ · Special | ZOLL Medical Corporation | 12/04/2008SE |
| K082861 | Amco Replacement Battery for Powerheart AED, Non-Rechargeable, Model 2L561; G3…MKJ · Traditional | Amco International Manufacturing & Design, Inc. | 11/25/2008SE |
| K081371 | Skintact Pediatric Multifunction Electrodes with DH03 GelMKJ · Traditional | Leonhard Lang GmbH | 09/24/2008SE |
| K073089 | Lifepak 20EMKJ · Traditional | Physio-Control, Inc. | 07/29/2008SE |
| K072923 | Zoll E Series DefibrillatorMKJ · Traditional | Zoll Medical Corporation, World Wide Headquarters | 04/24/2008SE |
| K080232 | Zoll E Series 12SL, Analysis OptionMKJ · Special | Zoll Medical Corporation, World Wide Headquarters | 04/23/2008SE |
| K073716 | Life+Cel or Lifecel BatteryMKJ · Traditional | Amco International Manufacturing & Design, Inc. | 04/11/2008SE |
| K080421 | Heart Sync, Models C-100 and T-100MKJ · Traditional | Heart Sync, LLC | 02/29/2008SE |
| K072812 | Philips Heartstart Smartpads IIIMKJ · Traditional | Philips Medical Systems | 02/26/2008SE |
| K072596 | Life+Cel or Lifecel Battery Pack, Model 5L500MKJ · Traditional | Amco International Manufacturing & Design, Inc. | 01/24/2008SE |
| K062970 | I-PadMKJ · Traditional | Cu Medical Systems, Inc. | 01/22/2008SE |
| K072430 | Zoll Pedipadz Reduced Energy ElectrodeMKJ · Traditional | ZOLL Medical Corporation | 11/06/2007SE |
| K072233 | Skintact Multifunctional Electrodes with DH02 Gel with Different Connectors Compatible…MKJ · Special | Leonhard Lang GmbH | 10/05/2007SE |
| K071025 | Zoll Aedpro with See-Thru CPR, Model AedproMKJ · Special | Zoll Medical Corporation, World Wide Headquarters | 06/22/2007SE |
| K070455 | Zoll E Series with See-Thru CPRMKJ · Special | Zoll Medical Corporation, World Wide Headquarters | 04/26/2007SE |
| K062537 | Zoll M Series with Real CPR HelpMKJ · Traditional | ZOLL Medical Corporation | 02/28/2007SE |
| K063510 | Lifepak 12 Defibrillator/MonitorMKJ · Special | Medtronic Emergency Response Systems, Inc. | 01/26/2007SE |
| K063375 | Heartstart MRX, Models M3535A or M3536AMKJ · Special | Philips Medical Systems | 01/11/2007SE |
| K063119 | Lifepak 20 Defibrillator/ MonitorMKJ · Special | Medtronic Emergency Response Systems, Inc. | 12/22/2006SE |
| K062177 | Zoll E Series with Real CPR HelpMKJ · Traditional | ZOLL Medical Corporation | 12/13/2006SE |
| K052465 | Reduced Energy Pediatric Electrode Pads for the Samaritan AED and Pad, Models Sde 251…MKJ · Traditional | Heartsine Technologies, Inc. | 12/12/2006SE |
| K062233 | Heartstart MRX Monitor/DefibrillatorMKJ · Special | Philips Medical Systems North America, Inc. | 11/22/2006SE |
| K060559 | Zoll R Series DefibrillatorMKJ · Traditional | ZOLL Medical Corporation | 08/17/2006SE |
| K061707 | Heartstart MRX, Invasive Pressure & Temperature OptionsMKJ · Abbreviated | Philips Medical Systems | 08/11/2006SE |
| K060934 | Modification to Powerheart EcdMKJ · Special | Cardiac Science Corporation | 05/15/2006SE |
| K052057 | Lifepak 500 Automated External DefibrillatorMKJ · Traditional | Medtronic Emergency Response Systems, Inc. | 02/17/2006SE |
| K052316 | Powerheart EcdMKJ · Traditional | Cardiac Science, Inc. | 01/03/2006SE |
| K042404 | Lifepak, Model 1000MKJ · Traditional | Medtronic Emergency Response Systems, Inc. | 12/22/2005SE |
| K052161 | Powerheart AED G3 (Model 9390E), Powerheart AED G3 Automatic (Model 9390A)MKJ · Special | Cardiac Science, Inc. | 10/21/2005SE |
| K051632 | Philips Heartstart FR2+ Automated External Defibrillator, Models M3860A, M3861A, M3840A…MKJ · Traditional | Philips Medical Systems | 10/05/2005SE |
| K051134 | Heartstart MRX with Q-Cpr Option, Models M3535A or M3536AMKJ · Traditional | Philips Medical Systems | 09/08/2005SE |
| K051475 | Zoll M Series 12SL Analysis OptionMKJ · Special | ZOLL Medical Corporation | 06/24/2005SE |
| K051076 | Zoll Stat*Padz MWP Multi-Function ElectrodesMKJ · Special | ZOLL Medical Corporation | 05/13/2005SE |
| K042007 | Zoll E Series DefibrillatorMKJ · Traditional | Zoll Medical Corp | 04/07/2005SE |
| K050004 | Philips Heartstart FRX Defibrillator, Model 861304MKJ · Special | Philips Medical Systems | 02/25/2005SE |
| K041892 | Zoll AED Pro External DefibrillatorMKJ · Traditional | ZOLL Medical Corporation | 02/04/2005SE |
| K042417 | Zoll M Series ETC02 Loflo OptionMKJ · Special | Zoll Medical Corp | 10/05/2004SE |
| K040479 | Pediatric Energy Reducer, Models AED-10 and AED-20MKJ · Traditional | Welch Allyn, Inc. | 09/14/2004SE |
| K041883 | Skintact Multifunction Electrodes, Model DF 21MKJ · Traditional | Leonhard Lang GmbH | 09/07/2004SE |
| K042088 | Samaritan Pad Pak Defibrillation Electrode, Model SPP-301MKJ · Traditional | Heartsine Technologies, Inc. | 09/02/2004SE |
| K040637 | Powerheart AED G3 ProMKJ · Traditional | Cardiac Science, Inc. | 08/06/2004SE |
| K041459 | Lifepak 12 Defibrillator/MonitorMKJ · Special | Medtronic Emergency Response Systems, Inc. | 07/01/2004SE |
| K040438 | Powerheart AED G3AMKJ · Traditional | Cardiac Science, Inc. | 07/01/2004SE |
| K033896 | Defibtech AED with Attenuated Defibrillation/Monitoring Pads, Models DDU-100 with DDP-200PMKJ · Traditional | Defibtech, LLC | 06/16/2004SE |
| K041067 | Heartsine Samaritan PadMKJ · Special | Heartsine Technologies, Inc. | 05/25/2004SE |
| K033642 | Smartlank Wireless, Model 001970MKJ · Traditional | Mrl, A Welch Allyn Company | 05/25/2004SE |
| K033474 | Zoll AED PlusMKJ · Traditional | Zoll Medical Corp | 05/21/2004SE |
| K040404 | Heartstart MRX, Model M3535AMKJ · Traditional | Philips Medical Systems, Inc. | 05/04/2004SE |
| K040775 | Lifepak 12MKJ · Special | Medtronic Physio-Control Corp. | 04/23/2004SE |
| K040256 | Pedi-Padz Radiolucent Multi-Function Pediatric Electrodes, Model 8900-1005MKJ · Traditional | Bio-Detek, Inc. | 04/09/2004SE |
| K040056 | Bio-Detek Electrode Adapter, Model R2001-90MKJ · Traditional | Bio-Detek, Inc. | 04/09/2004SE |
| K033771 | Bio-Detek Modified Adult Multi-Function Electrode with ConnectorMKJ · Traditional | Bio-Detek, Inc. | 02/27/2004SE |
| K032421 | Ambu Pediatric Multi-Function Defibrillation ElectrodeMKJ · Traditional | Ambu, Inc. | 02/27/2004SE |
| K032051 | Battery Pack, Rechargeable, Models MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649PMKJ · Traditional | Access Battery, Inc. | 01/09/2004SE |
| K033144 | Defibtech Electrode Adapter, Model DAC-300 SeriesMKJ · Traditional | Defibtech, LLC | 11/13/2003SE |
| K033275 | Lifepak 12, 20, 500, CR PlusMKJ · Special | Medtronic Physio-Control Corp. | 11/06/2003SE |
| K032439 | Zoll M Series with Rectilinear Bi-Phasic Option (M Series Bi-Phasic)MKJ · Abbreviated | Zoll Medical Corp | 11/05/2003SE |
| K031187 | Heartstart MRX, Model M3535AMKJ · Abbreviated | Philips Medical Systems | 08/27/2003SE |
| K030898 | Mobile Battery Service Station (MBSS)MKJ · Traditional | Ad Elektronik GmbH | 08/27/2003SE |
| K031987 | Powerheart AED G3, Model 9300MKJ · Special | Cardiac Science | 07/30/2003SE |
| K023854 | Samaritan AED, Model SAM-01MKJ · Traditional | Heartsine Technologies, Inc. | 02/14/2003SE |
| K022929 | Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart AED, Model…MKJ · Traditional | Cardiac Science, Inc. | 01/27/2003SE |
| K022732 | Infant/Child Reduced Energy ElectrodesMKJ · Traditional | Medtronic Physio-Control Corp. | 12/13/2002SE |
| K020715 | Philips M5066A and M5068AMKJ · Abbreviated | Philips Medical Systems | 11/08/2002ST |
| K022210 | Multifunctional Electrode Models 9640, 9650MKJ · Traditional | Cardiac Science, Inc. | 10/04/2002SE |
| K020984 | Accessaed, Semi-Automatic External DefibrillatorsMKJ · Traditional | Access Cardiosystems, Inc. | 08/14/2002ST |
| K021453 | Heartstream XL Defibrillator/Monitor, Model #M4735AMKJ · Traditional | Philips Medical Systems | 07/03/2002SE |
| K021168 | Jump Start, Model 970300MKJ · Traditional | Medical Research Laboratories, Inc. | 06/26/2002ST |
| K013896 | Sentry Semiautomatic External Defibrillator; External Defibrillation Pads (Electrodes)…MKJ · Traditional | Defibtech, LLC | 06/19/2002ST |
| K020743 | Padpro, Model 2502MKJ · Traditional | Padpro, LLC | 05/28/2002SE |
| K020203 | Padpro Model #2516MKJ · Special | Padpro, LLC | 05/08/2002SE |
| K011541 | Zoll Pad with CPR AidMKJ · Traditional | Zoll Medical Corp | 04/11/2002ST |
| K011388 | Zoll PadMKJ · Traditional | Zoll Medical Corp | 03/25/2002SE |
| K020288 | Padpro, Model 2603MKJ · Special | Padpro, LLC | 02/27/2002SE |
| K011901 | Firstsave Star Biphasic, Model 9210/9200MKJ · Traditional | Survivalink Corp. | 02/01/2002SE |
| K012766 | Portable Intensive Care UnitMKJ · Traditional | Medical Research Laboratories, Inc. | 01/23/2002ST |
| K014209 | Padpro Model 2001, 2001-S, 2001-C, 2001-EPSMKJ · Special | Padpro, LLC | 01/18/2002SE |
| K014157 | HEARTSTREAMFR2 AED with M3848A and M3849A, Models M3860A, M3861, M3840A, M3841AMKJ · Special | Philips Medical Systems | 01/17/2002ST |
| K013425 | Heartstream/Heartstart FR2 AED ECG Cable, Models M3860A, M3861A, M3840A, M3841AMKJ · Traditional | Philips Medical Systems | 01/14/2002SE |
| K011144 | Lifepak 600 Automated External DefibrillatorMKJ · Traditional | Medtronic Physio-Control Corp. | 12/03/2001SE |
| K012197 | Powerheart Cardiac Rhythm ModuleMKJ · Traditional | Cardiac Science, Inc. | 11/16/2001SE |
| K012428 | Modification to: Lifepak 500 Automated External DefibrillatorMKJ · Special | Medtronic Physio-Control Corp. | 09/28/2001SE |
| K012030 | Portable Intensive Care UnitMKJ · Traditional | Medical Research Laboratories, Inc. | 09/24/2001SE |
| K003548 | Padpro System Defibrillator Electrode AdaptersMKJ · Traditional | Padpro, LLC | 09/04/2001SE |
| K010918 | Lifepak 12 Defibrillator/Monitor SystemMKJ · Traditional | Medtronic Physio-Control Corp. | 08/23/2001ST |
| K010207 | Portable Instensive Care UnitMKJ · Special | Medical Research Laboratories, Inc. | 06/14/2001ST |
| K010634 | Heartstream XL Defibibrillator/Monitor, Model M4735A, Heartstream XLT…MKJ · Traditional | Agilent Technologies, Inc. | 06/11/2001SE |
| K003819 | Heartstream Attenuated Defibrillation Pads, Model M3870AMKJ · Traditional | Agilent Technologies, Inc. | 05/02/2001SE |
| K010257 | Zoll M SeriesMKJ · Special | Zoll Medical Corp | 02/28/2001SE |
| K010214 | Firstsave Biphasic Model #9200 and 9210MKJ · Special | Survivalink Corp. | 02/22/2001SE |
| K002079 | Multi-Function Defibrillation ElectrodeMKJ · Traditional | Medicotest A/S | 02/22/2001SE |
| K002280 | Pad Pro Pediatric Electrode, Model Pad Pro 2602MKJ · Traditional | Medical Devices, Inc. | 02/05/2001SE |
| K002445 | Lifepak 12DEFIBERLLATOR/MONITOR SeriesMKJ · Traditional | Medtronic Physio-Control Corp. | 01/31/2001ST |
| K003565 | Heartstream FR2 AED, Model M3860A,M3861AMKJ · Special | Agilent Technologies, Inc. | 12/20/2000SE |
| K003228 | K-Defib/Pace Multifuction Pediatric Electrode, Model KDP-70AMKJ · Traditional | Katecho, Inc. | 12/14/2000SE |
| K002232 | AedefibrillatorMKJ · Traditional | Medical Research Laboratories, Inc. | 12/06/2000SE |
| K002806 | K-Defib/Pace, Model KDP-60AMKJ · Traditional | Katecho, Inc. | 11/21/2000SE |
| K000638 | Responder 3000MKJ · Traditional | Ge Medical Systems Information Technologies GmbH | 10/30/2000SE |
| K001725 | Heartstream XL Defibrillator/Monitor, Model M4735AMKJ · Traditional | Agilent Technologies, Inc. | 09/08/2000SE |
| K992543 | Heartstream XLT Defibrillator/Monitor, Ac Charger, DC Charger, Data Card, Single Bay…MKJ · Traditional | Hewlett-Packard Co. | 05/18/2000SE |
| K993036 | Zoll M Series ETCO2 OptionMKJ · Traditional | Zoll Medical Corp | 02/28/2000ST |
| K993745 | K-Defib/Pace Adult Electrode, Model KDP-80MKJ · Traditional | Katecho, Inc. | 02/03/2000SE |
| K993533 | Powerheart AecdMKJ · Special | Cardiac Science, Inc. | 01/24/2000ST |
| K993072 | Survivalink Multifunctional Electrode (SVL-9630)MKJ · Traditional | Survivalink Corp. | 12/10/1999SE |
| K992977 | Hewlett Packard Multifunction Pediatric Defib Function, Model M3503A & M3504AMKJ · Traditional | Hewlett-Packard Co. | 12/01/1999SE |
| K991556 | Zoll M Series 12SL Analysis OptionMKJ · Traditional | Zoll Medical Corp | 10/21/1999ST |
| K991910 | Lifepak 12 BiphasicMKJ · Traditional | Physio-Control Corp. | 09/03/1999ST |
| K990762 | Zoll M Series with Rectilinear Bi-Phasic Option (M Series Bi-Phasic)MKJ · Traditional | Zoll Medical Corp | 09/03/1999ST |
| K991007 | K-Defib/Pace Radiolucent Adult Electrode, Model KRT-60MKJ · Traditional | Katecho, Inc. | 08/23/1999SE |
| K991871 | Hewlett Packard Multi Function Adult Defib Electrode, Model M3501A & M3502AMKJ · Traditional | Hewlett-Packard Co. | 08/05/1999SE |
| K983393 | Lifepak 500 BiphasicMKJ · Traditional | Physio-Control Corp. | 05/05/1999ST |
| K984582 | Zoll Superpadz Adult Multi-Function Electrodes, Model 8900-XXXXMKJ · Traditional | Bio-Detek, Inc. | 03/16/1999SE |
| K982992 | Zoll M Series SPO2 OptionMKJ · Traditional | Zoll Medical Corp | 03/11/1999ST |
| K990106 | Zoll First Responder Padz Adult Defibrillation ElectrodesMKJ · Traditional | Bio-Detek, Inc. | 02/26/1999SE |
| K982264 | Firstsave Biphasic Models 9200 and 9210MKJ · Traditional | Survivalink Corp. | 01/25/1999ST |
| K984286 | Heartstream Electrode AdapterMKJ · Special | Hewlett-Packard Co. | 12/17/1998SE |
| K981737 | K-Defib/Pace Adult Electrode Model Number KDP-60MKJ · Traditional | Katecho, Inc. | 12/09/1998SE |
| K981802 | Zoll Stat*Padz Adult Multi-Function Electrodes Model Number 8900-4003MKJ · Traditional | Bio-Detek, Inc. | 11/25/1998SE |
| K983307 | Modification to Portable Intensive Care UnitMKJ · Special | Medical Research Laboratories, Inc. | 11/20/1998SE |
| K983287 | Medi-Trace 1610C Combination Defibrillation, Monitoring and Pacing ElectrodeMKJ · Traditional | Graphic Controls Corp. | 11/05/1998SE |
| K982025 | Hewlett-Packard M2475B with 12-LEAD Option (#C90) Codemaster 100 Conitor/DefibrillatorMKJ · Traditional | Hewlett-Packard Co. | 09/04/1998ST |
| K982710 | Aecd Arrhythmia Detection SoftwareMKJ · Special | Cardiac Science, Inc. | 08/10/1998ST |
| K965117 | Life Support for Trauma and TransportMKJ · Traditional | Northrop Grumman Corp. | 06/26/1998ST |
| K980857 | Medi-Trace 1310P Combination Defibrillation, Monitoring & Pacing ElectrodeMKJ · Traditional | Graphic Controls Corp. | 05/12/1998SE |
| K972241 | Zoll ReviverMKJ · Traditional | Zoll Medical Corp | 03/16/1998SE |
| K973486 | Life Pak 12MKJ · Traditional | Physio-Control Corp. | 01/09/1998SE |
| K962359 | Lifepak 300MKJ · Traditional | Physio-Control Corp. | 11/06/1997SE |
| K970741 | Powerheart AecdMKJ · Traditional | Cardiac Science, Inc. | 10/16/1997SE |
| K972418 | Heartstramelectrode Adapter(Ea-Xx Series)/Heartstram Defibrillation Pads with…MKJ · Traditional | Heartstream, Inc. | 09/25/1997SE |
| K972970 | Medi-Trace 1510M Combination Defibrillation, Monitoring and Pacing ElectrodeMKJ · Traditional | Graphic Controls Corp. | 08/27/1997SE |
| K955890 | First Medic Pulse Oximetry ModuleMKJ · Traditional | Colorado Medtech, Inc. | 07/28/1997SE |
| K971149 | SVL-9130 Defibrillation ElectrodeMKJ · Traditional | Survivalink Corp. | 06/23/1997SE |
| K971148 | 700-SP Series Disposable Stimulation ElectrodesMKJ · Traditional | Cardiotronics Systems, Inc. | 05/15/1997SE |
| K970719 | 700-MP Disposable Radiolucent Multi-Pad ElectrodesMKJ · Traditional | Cardiotronics Systems, Inc. | 04/16/1997SE |
| K970391 | Quantum Edge Pediatric Defirbrillation ElectrodesMKJ · Traditional | Contour Medical Technology, Inc. | 03/06/1997SE |
| K964991 | 700-FR Series Radiolucent Stimulation ElectrodesMKJ · Traditional | Cardiotronics Systems, Inc. | 01/15/1997SE |
| K955854 | Lifepak 500MKJ · Traditional | Physio-Control Corp. | 11/04/1996SE |
| K955923 | Medi-Trace Combination Defibrillation & ECG Electrode for LaerdalMKJ · Traditional | Graphic Controls Corp. | 10/24/1996SE |
| K955882 | Medi-Trace Combination Defibrillation & ECG Electrode for Hewlett Packard DefibrillatorsMKJ · Traditional | Graphic Controls Corp. | 10/24/1996SE |
| K955628 | Fore Runner External Defibrillator/Defibrillator PadsMKJ · Traditional | Heartstream, Inc. | 09/10/1996SE |
| K955828 | Medi-Trace Combination Defibrillation & ECG Electrode for Physio Control DefibrillatorsMKJ · Traditional | Graphic Controls Corp. | 07/25/1996SE |
PMA approvals
- P200005 TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors · Tz Medical, Inc. · 01/09/2024
- P200007 HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads · Graphic Controls D.B.A. Vermed · 06/23/2023
- P210015 Avive Automated External Defibrillator (AED) System · Avive Solutions, Inc. · 10/31/2022
- P200004 ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters · Conmed Corporation · 09/26/2021
- P190013 AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE) · Aed Battery Exchange, LLC · 02/02/2021
- P190007 Cardinal Health Multifunctional Defibrillation Electrode · Cardinalhealth · 08/07/2020
- P180028 HeartStart FRx Defibrillator · Philips Medical Systems · 05/11/2020
- P160028 Philips HeartStart FR3 Defibrillator · Philips Medical Systems, Inc. · 05/11/2020
- P170018 LIFEPAK® CR2 Defibrillator · Physio-Control, Inc. · 12/21/2018
- P160033 Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3 · ZOLL Medical Corporation · 12/07/2018
- P160034 Powerheart® AED G3 Pro · ZOLL Medical Corporation · 12/06/2018
- P160026 Lifepak 1000 Defibrillator, Lifepak 20 Defibrillator/ Monitor, Lifepak 20E Defibrillator/ Monitor, Lifepak 15 Monitor/De · Physio-Control, Inc. · 07/02/2018
- P160032 Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU- · Defibtech, LLC · 02/01/2018
- P160022 X Series®, R Series®, AED Pro®, AED 3 BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower · ZOLL Medical Corporation · 12/27/2017
- P160012 LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger · Physio-Control, Inc. · 12/21/2017
- P160015 AED Plus and Fully Automatic AED Plus · ZOLL Medical Corporation · 05/26/2017
- P160008 HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) · Heartsine Technologies, Ltd. · 01/12/2017
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3120-2026 Class II | HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067…Due to a damaged (over stretched) membrane tail that causes an intermittent fault. | HeartSine Technologies Ltd | 07/27/2026Open, Classified |
| Z-2065-2026 Class II | LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241…Some defibrillators serviced between July 2023 through November 2025 were serviced without objective… | Physio-Control, Inc. | 04/13/2026Open, Classified |
| Z-1544-2026 Class II | PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers:…Due to pediatric defibrillator electrode delamination | Physio-Control, Inc. | 01/21/2026Open, Classified |
| Z-0288-2026 Class II | HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07…Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and… | HeartSine Technologies Ltd | 09/18/2025Open, Classified |
| Z-2499-2025 Class II | LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911…Due to required inspections not being performed on products/units that have gone through servicing. | Physio-Control, Inc. | 07/22/2025Open, Classified |
| Z-2498-2025 Class II | LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 /…Due to required inspections not being performed on products/units that have gone through servicing. | Physio-Control, Inc. | 07/22/2025Open, Classified |
| Z-2497-2025 Class II | LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 /…Due to required inspections not being performed on products/units that have gone through servicing. | Physio-Control, Inc. | 07/22/2025Open, Classified |
| Z-2174-2025 Class II | HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan…Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver… | HeartSine Technologies Ltd | 06/30/2025Open, Classified |
| Z-1694-2025 Class II | Automated External Defibrillators, Model DDU-2200, IItem numbers:…It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical… | Defibtech, LLC | 03/18/2025Open, Classified |
| Z-1693-2025 Class II | Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German…It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical… | Defibtech, LLC | 03/18/2025Open, Classified |
| Z-1692-2025 Class II | Automated External Defibrillators, Model DDU-2300. Item numbers:…It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical… | Defibtech, LLC | 03/18/2025Open, Classified |
| Z-1691-2025 Class II | Automated External Defibrillators, Model DDU-2200, IItem numbers:…It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical… | Defibtech, LLC | 03/18/2025Open, Classified |
| Z-1690-2025 Class II | Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers:…It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical… | Defibtech, LLC | 03/18/2025Open, Classified |
| Z-1323-2025 Class II | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80A; Software…The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments… | ZOLL Medical Corporation | 02/13/2025Open, Classified |
| Z-1322-2025 Class II | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO…The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments… | ZOLL Medical Corporation | 02/13/2025Open, Classified |
| Z-1321-2025 Class II | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; Software…The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments… | ZOLL Medical Corporation | 02/13/2025Open, Classified |
| Z-1320-2025 Class II | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2)…The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments… | ZOLL Medical Corporation | 02/13/2025Open, Classified |
| Z-1319-2025 Class II | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2)…The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments… | ZOLL Medical Corporation | 02/13/2025Open, Classified |
| Z-1318-2025 Class II | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80C, (2)…The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments… | ZOLL Medical Corporation | 02/13/2025Open, Classified |
| Z-1317-2025 Class II | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2)…The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments… | ZOLL Medical Corporation | 02/13/2025Open, Classified |
| Z-1316-2025 Class II | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2)…The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments… | ZOLL Medical Corporation | 02/13/2025Open, Classified |
| Z-1232-2025 Class II | LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in…Incorrect keypad was incorrectly installed onto a defibrillator/monitor. | Physio-Control, Inc. | 02/03/2025Open, Classified |
| Z-1184-2025 Class II | LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo RD rainbow Adt 8 SpCO, SpO2, and SpMet…Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin… | Physio-Control, Inc. | 01/21/2025Open, Classified |
| Z-0505-2025 Class II | Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: Lifeline View…Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized… | Defibtech, LLC | 10/14/2024Open, Classified |
| Z-0504-2025 Class II | Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View…Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized… | Defibtech, LLC | 10/14/2024Open, Classified |
| Z-0503-2025 Class II | Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline…Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized… | Defibtech, LLC | 10/14/2024Open, Classified |
| Z-0502-2025 Class II | Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and…Within the Irish Market, a Field Safety Notice is being issued due to a select number of authorized labelled… | Defibtech, LLC | 10/14/2024Open, Classified |
| Z-0230-2025 Class II | LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o…Due to an out of tolerance tool being used on monitor/defibrillator systems. | Physio-Control, Inc. | 08/30/2024Open, Classified |
| Z-2324-2024 Class II | ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator…G5 Semi-Automatic AED is shipped, with a protective film over its front panel, to protect the screen and… | Zoll Medical Corporation | 05/31/2024Open, Classified |
| Z-1820-2024 Class II | HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450PAutomated external defibrillators have a manufacturing issue that could prevent the device from delivering… | HeartSine Technologies Ltd | 04/08/2024Open, Classified |
| Z-1141-2024 Class II | HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM…Automated external defibrillators were shipped in their test configuration so there is a potential to have… | HeartSine Technologies Ltd | 02/14/2024Open, Classified |
| Z-0567-2024 Class II | AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the… | Physio-Control, Inc. | 11/06/2023Open, Classified |
| Z-0305-2024 Class II | LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | Physio-Control, Inc. | 09/29/2023Open, Classified |
| Z-0304-2024 Class II | LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | Physio-Control, Inc. | 09/29/2023Open, Classified |
| Z-0303-2024 Class II | LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | Physio-Control, Inc. | 09/29/2023Open, Classified |
| Z-0302-2024 Class II | LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | Physio-Control, Inc. | 09/29/2023Open, Classified |
| Z-0301-2024 Class II | LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | Physio-Control, Inc. | 09/29/2023Open, Classified |
| Z-0300-2024 Class II | LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | Physio-Control, Inc. | 09/29/2023Open, Classified |
| Z-0299-2024 Class II | LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | Physio-Control, Inc. | 09/29/2023Open, Classified |
| Z-0298-2024 Class II | LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | Physio-Control, Inc. | 09/29/2023Open, Classified |
| Z-0297-2024 Class II | LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | Physio-Control, Inc. | 09/29/2023Open, Classified |
| Z-0296-2024 Class II | LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | Physio-Control, Inc. | 09/29/2023Open, Classified |
| Z-2143-2023 Class II | HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with…Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cells which… | HeartSine Technologies Ltd | 04/26/2023Open, Classified |
| Z-1312-2023 Class II | DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of…A component of a sub-assembly used in the affected AEDs had not undergone durability and reliability… | Defibtech, LLC | 02/14/2023Open, Classified |
| Z-1217-2023 Class II | Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic…Automated external defibrillators were potentially distributed with the incorrect language configuration… | HeartSine Technologies Ltd | 02/01/2023Open, Classified |
| Z-0882-2022 Class II | Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS…There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from… | Philips North America LLC | 02/04/2022Open, Classified |
| Z-0881-2022 Class II | Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1…There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from… | Philips North America LLC | 02/04/2022Open, Classified |
| Z-0745-2022 Class III | HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-PakSemi-automatic defibrillators shipped out by Stryker without battery and electrode packs. | Physio-Control, Inc. | 01/13/2022Terminated |
| Z-2427-2021 Class II | Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55…Infant/Child defibrillator pads contain incorrect labeling. This could lead to a delay in therapy, or… | Philips North America LLC | 07/16/2021Terminated |
| Z-0081-2022 Class II | Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067ACustomers were not notified of previous recalls associated with various defibrillator models. | Philips North America LLC | 02/09/2021Open, Classified |