Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
FDA product code DRO · Class II (moderate risk) · 21 CFR 870.5550 · Cardiovascular
84510(k) clearances
0PMA approvals
22recalls
Manufacturers
- Cardiac Resucitator Corp. 13
- Physio-Control Corp. 10
- Cardiotronics, Inc. 9
- Medac, Inc. 8
- Katecho, Inc. 4
- Zmi Corp. 4
- Medical Data Electronics 3
- Andover Medical, Inc. 2
- Medical Research Laboratories, Inc. 2
- Darox Corp. 2
- Conmedcorp 2
- Medtronic Vascular 2
- Hewlett-Packard Co. 2
- Tz Medical, Inc. 2
- Marquette Electronics, Inc. 2
- Micromedical Devices, Inc. 2
- Ross Research, Inc. 2
- Biotronics Corp. 1
- A.M.I. Corp. 1
- The Ludlow Company LP 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K012404 | K-Defib/Pace Adult Electrode, Model KDP-85DRO · Traditional | Katecho, Inc. | 10/12/2001SE |
| K012218 | Ludlow Gradient Edge Adult & Pediatric Multifunctional ElectrodesDRO · Traditional | The Ludlow Company LP | 10/12/2001SE |
| K000660 | Escort Ii+ 400 Series (Escort Prism), Model 20400, 20401, 20403, Monitor, Models 20411…DRO · Special | Medical Data Electronics | 03/28/2000SE |
| K983232 | Padtak Pediatric Defib/Cardiovert/Pace/Monitor-Radiotransparent (2X2.25),MODEL 2602…DRO · Traditional | Tz Medical, Inc. | 09/15/1999SE |
| K983196 | Padtak Pace/Defib/Cardiovert Monitoring Electrode(S)DRO · Traditional | Tz Medical, Inc. | 09/15/1999SE |
| K974034 | Portable Intensive Care UnitDRO · Traditional | Medical Research Laboratories, Inc. | 03/02/1998SE |
| K962547 | Cardioserv PDRO · Traditional | Marquette Electronics, Inc. | 03/06/1997SE |
| K963120 | Responder 2500 Defibrillator and Cardiac Care SystemDRO · Traditional | Marquette Electronics, Inc. | 02/28/1997SE |
| K961138 | Esort II + 400 Series MonitorDRO · Traditional | Medical Data Electronics | 12/10/1996SE |
| K951593 | Lifepak 11DRO · Traditional | Physio-Control Corp. | 12/29/1995SE |
| K950856 | Zoll PD2000 Pacemaker/Advisory Defibrillator, Model PD2000, Zoll D2000 Advisory…DRO · Traditional | Zoll Medical Corp | 12/29/1995SE |
| K950483 | Hewlett Packard M2475B Codemaster 100 Defibrillator/MonitorDRO · Traditional | Hewlett-Packard Co. | 05/22/1995SE |
| K926175 | K-Defib/Pace Carbon ElectrodeDRO · Traditional | Katecho, Inc. | 04/15/1993SE |
| K915757 | Models M1722A, M1723A, M1724A DefibrillatorsDRO · Traditional | Hewlett-Packard Co. | 07/30/1992SE |
| K915328 | Gel-TacDRO · Traditional | Katecho, Inc. | 06/29/1992SE |
| K914955 | K-Defib/Pace ElectrodeDRO · Traditional | Katecho, Inc. | 05/14/1992SE |
| K912599 | Quik-Pace(R) or Ex-Pace(Tm) Pediatric Pacing ElecDRO · Traditional | Physio-Control Corp. | 09/11/1991SE |
| K911956 | Zoll PD-1400 Pacer/DefibrillatorDRO · Traditional | Zmi Corp. | 07/31/1991SE |
| K910661 | Model 205 Shock-TrodeDRO · Traditional | Cardiotronics, Inc. | 05/02/1991SE |
| K903437 | Dispos Access External Cardiac PacemakerDRO · Traditional | Keller Medical Specialties Products, Inc. | 11/16/1990SE |
| K894492 | Nka Model SEC-3102 Cardiac StimulatorDRO · Traditional | Nihon Kohden America, Inc. | 12/20/1989SE |
| K894588 | Defib/Pacing PadsDRO · Traditional | Conmedcorp | 10/26/1989SE |
| K895729 | R2 Pace Pad, Model 480DRO · Traditional | Darox Corp. | 10/12/1989SE |
| K895728 | R2 Pace Adaptor Cable, Model 196DRO · Traditional | Darox Corp. | 10/12/1989SE |
| K885166 | Zmi Part No. NTP-2100, Pediatric ElectrodesDRO · Traditional | Zmi Corp. | 05/01/1989SE |
| K885171 | Modified Label Change to Model 5455 Surgical CableDRO · Traditional | Andover Medical, Inc. | 01/12/1989SE |
| K880932 | MRL Pacette, 450SLLDRO · Traditional | Medical Research Laboratories, Inc. | 12/16/1988SE |
| K884532 | Triad-Ep II, Pushbutton, Cable InputDRO · Traditional | Cardiotronics, Inc. | 11/18/1988SE |
| K884530 | Triad-Ep II, Plate InputDRO · Traditional | Cardiotronics, Inc. | 11/17/1988SE |
| K883304 | Traid-Ep, Plate Input, W/Pulse Blanking CircuitryDRO · Traditional | Cardiotronics, Inc. | 11/09/1988SE |
| K883178 | Triad-Ep, Pushbutton, Cable Input TypeDRO · Traditional | Cardiotronics, Inc. | 11/09/1988SE |
| K883523 | Triad-Ep, Pushbutton, Cable Input Type, W/PulseDRO · Traditional | Cardiotronics, Inc. | 10/06/1988SE |
| K883121 | Quik-Pace II ElectrodesDRO · Traditional | Physio-Control Corp. | 09/20/1988SE |
| K883375 | Model #918 Multi-PadsDRO · Traditional | Cardiotronics, Inc. | 08/30/1988SE |
| K882338 | Model #716 Adult Stim. Pads Low Impedance Gel TypeDRO · Traditional | Cardiotronics, Inc. | 08/30/1988SE |
| K882168 | External Pacemaker 2000 (EP2000)DRO · Traditional | Unomed, Inc. | 08/19/1988SE |
| K880936 | Triad-EpDRO · Traditional | Cardiotronics, Inc. | 07/18/1988SE |
| K874447 | Disposable Gel Defibrillation/External Pacing ElecDRO · Traditional | Medac, Inc. | 01/27/1988SE |
| K871751 | Quik-Pace Noninvasive PacemakerDRO · Traditional | Physio-Control Corp. | 12/29/1987SE |
| K874090 | 300M ECG Monitro/Transcutaneous PacemakerDRO · Traditional | Medac, Inc. | 12/15/1987SE |
| K873402 | Zoll NTP-1200 Pacer/DefibrillatorDRO · Traditional | Zmi Corp. | 11/23/1987SE |
| K872778 | PacestartDRO · Traditional | Pacific Rim Engineering & Mfg. | 11/04/1987SE |
| K872368 | Modified Versa Stim Electrode LineDRO · Traditional | Conmedcorp | 09/18/1987SE |
| K872012 | Lectec Non-Invasive Pacing ElectrodeDRO · Traditional | Lectec Corp. | 06/29/1987SE |
| K871971 | Modified Pace*Aid Model 53DRO · Traditional | Cardiac Resucitator Corp. | 06/24/1987SE |
| K871538 | Stat-Pad (TM)DRO · Traditional | Cardiac Resucitator Corp. | 06/24/1987SE |
| K871569 | Modified Heart*Aid 97 Auto. External DefibrillatorDRO · Traditional | Cardiac Resucitator Corp. | 06/08/1987SE |
| K871176 | Pace 10 Non-Invasive External PacemakerDRO · Traditional | Medac, Inc. | 04/23/1987SE |
| K864985 | Dispos Gel External Pacing Electrode/Low ImpedanceDRO · Traditional | Medac, Inc. | 03/10/1987SE |
| K864989 | Etp 180A Non-Invasive External PacemakerDRO · Traditional | Medac, Inc. | 03/03/1987SE |
| K864988 | Etp 180E Non-Invasive External PacemakerDRO · Traditional | Medac, Inc. | 03/03/1987SE |
| K864987 | Dispos Gel External Pacing Electrode/Hi ImpedanceDRO · Traditional | Medac, Inc. | 03/03/1987SE |
| K864986 | Etp 300 Non-Invasive External PacemakerDRO · Traditional | Medac, Inc. | 03/03/1987SE |
| K863547 | Medtronic Model 5455 Disposable Surgical CableDRO · Traditional | Medtronic Vascular | 10/31/1986SE |
| K862298 | Alternate Size E-Z-Pace ElectrodeDRO · Traditional | Medtronic Vascular | 07/11/1986SE |
| K854196 | Dci Model EP-2 Clinical StimulatorDRO · Traditional | Digital Cardiovascular Instruments, Inc. | 05/01/1986SE |
| K860551 | Etp 180 Cardiac Pacemaker (External)DRO · Traditional | Biotronics Corp. | 04/30/1986SE |
| K860283 | Ami Cardio-PadDRO · Traditional | Andover Medical, Inc. | 03/31/1986SE |
| K855015 | Noninvasive Temp. Pacemaker NTP-1000DRO · Traditional | Zmi Corp. | 03/31/1986SE |
| K854924 | Ami E-Z-Pace ElectodeDRO · Traditional | A.M.I. Corp. | 02/26/1986SE |
| K854853 | Ni-Pacer 1DRO · Traditional | Associated Medical Devices, Inc. | 02/14/1986SE |
| K854117 | Amendment Lifepak 8, NPN 052DRO · Traditional | Physio-Control Corp. | 01/13/1986SE |
| K854233 | Cmi 3000DRO · Traditional | Cardio Management, Inc. | 01/08/1986SE |
| K853732 | Lifepak 8 ModificationDRO · Traditional | Physio-Control Corp. | 12/09/1985SE |
| K850812 | Emergipace - External PacemakerDRO · Traditional | Life Science Instrumentation, Inc. | 11/05/1985SE |
| K852958 | PacepacDRO · Traditional | Medical Data Electronics | 10/11/1985SE |
| K850791 | Mdi 2000 - Pulse GeneratorDRO · Traditional | Micromedical Devices, Inc. | 06/19/1985SE |
| K851248 | Amendment Lifepak 100, NPN 045DRO · Traditional | Physio-Control Corp. | 04/19/1985SE |
| K851247 | Amendment Lifepak 200, NPN 046DRO · Traditional | Physio-Control Corp. | 04/19/1985SE |
| K850596 | Pace*Aid 10 a -Pad 10A- Pacemaker Output Display &DRO · Traditional | Cardiac Resucitator Corp. | 03/06/1985SE |
| K850170 | Heart Aid Model 97DRO · Traditional | Cardiac Resucitator Corp. | 02/14/1985SE |
| K844811 | Pace Aid Model 53DRO · Traditional | Cardiac Resucitator Corp. | 01/24/1985SE |
| K843547 | Pace *Aid Model 52DRO · Traditional | Cardiac Resucitator Corp. | 12/17/1984SE |
| K843358 | Heart-Aid Model 80DRO · Traditional | Cardiac Resucitator Corp. | 11/19/1984SE |
| K840353 | Pacemaker Pulse Generator W/ElectrodeDRO · Traditional | Ross Research, Inc. | 04/23/1984SE |
| K840047 | Lifepak 7DDRO · Traditional | Physio-Control Corp. | 02/04/1984SE |
| K834262 | Trans-PaceDRO · Traditional | Micromedical Devices, Inc. | 02/04/1984SE |
| K832876 | Lifepak 7PDRO · Traditional | Physio-Control Corp. | 01/30/1984SE |
| K822246 | Noninvasive Temporary PacemakerDRO · Traditional | Ross Research, Inc. | 08/06/1982SE |
| K821673 | Heart*Aid, Als, Model 95DRO · Traditional | Cardiac Resucitator Corp. | 08/06/1982SE |
| K821152 | Heart Aid #90DRO · Traditional | Cardiac Resucitator Corp. | 08/06/1982SE |
| K820609 | Heart *Aid, #80DRO · Traditional | Cardiac Resucitator Corp. | 08/06/1982SE |
| K820507 | Pace* Aid Model 50DRO · Traditional | Cardiac Resucitator Corp. | 08/06/1982SE |
| K813553 | Pace *AidDRO · Traditional | Cardiac Resucitator Corp. | 01/18/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0103-2022 Class II | smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. | Smiths Medical ASD Inc. | 03/10/2020Terminated |
| Z-0102-2022 Class II | smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. | Smiths Medical ASD Inc. | 03/10/2020Terminated |
| Z-0101-2022 Class II | smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. | Smiths Medical ASD Inc. | 03/10/2020Terminated |
| Z-0100-2022 Class II | smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. | Smiths Medical ASD Inc. | 03/10/2020Terminated |
| Z-0099-2022 Class II | smiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. | Smiths Medical ASD Inc. | 03/10/2020Terminated |
| Z-0098-2022 Class II | smiths medical medex CBSS 5 ml, zweifach proximaler Entnahmeport 60 cm, Model Number…Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. | Smiths Medical ASD Inc. | 03/10/2020Terminated |
| Z-0097-2022 Class II | smiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm, Model Number…Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. | Smiths Medical ASD Inc. | 03/10/2020Terminated |
| Z-0096-2022 Class II | smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model number…Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. | Smiths Medical ASD Inc. | 03/10/2020Terminated |
| Z-0095-2022 Class II | smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Model Number…Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. | Smiths Medical ASD Inc. | 03/10/2020Terminated |
| Z-0094-2022 Class II | smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. | Smiths Medical ASD Inc. | 03/10/2020Terminated |
| Z-0093-2022 Class II | smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pressure…Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. | Smiths Medical ASD Inc. | 03/10/2020Terminated |
| Z-0092-2022 Class II | medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b)…Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. | Smiths Medical ASD Inc. | 03/10/2020Terminated |
| Z-2546-2015 Class II | MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsterile Item…Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulation may… | Covidien LLC | 08/19/2015Terminated |
| Z-2545-2015 Class II | MediTrace Cadence Adult Multi-Function Defibrillation Electrodes Item Code:22550PCMulti-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulation may… | Covidien LLC | 08/19/2015Terminated |
| Z-0048-2015 Class I | Philips HEARTSTART Multifunction Electrode Pads Part Number: M3718ACovidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model… | Covidien LLC | 09/18/2014Terminated |
| Z-0045-2015 Class I | Covidien Kendall Adult Multi-Function Defibrillation Electrodes Part Number: 20660Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model… | Covidien LLC | 09/18/2014Terminated |
| Z-0044-2015 Class I | Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connected…Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model… | Covidien LLC | 09/18/2014Terminated |
| Z-0043-2015 Class I | Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes…Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model… | Covidien LLC | 09/18/2014Terminated |
| Z-1438-2013 Class II | adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model…TZ Medical Inc is recalling its P-211-M1 and P-214-M1 Medtronic / Physio Control Compatible transparent… | TZ Medical Inc. | 04/30/2013Terminated |
| Z-1185-2013 Class II | Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID:…Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the… | Covidien LLC | 04/08/2013Terminated |
| Z-1184-2013 Class II | Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R.…Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the… | Covidien LLC | 04/08/2013Terminated |
| Z-0937-2011 | Welch Allyn PIC 50 Portable Intensive Care System. Model 971081 series. Designed for use…Potential likelihood that the Portable Intensive Care (PIC) 50 Defibrillator's screen display may fail. The… | Welch Allyn Protocol, Inc | 09/17/2010Terminated |