Ventilator, Emergency, Powered (Resuscitator)
FDA product code BTL · Class II (moderate risk) · 21 CFR 868.5925 · Anesthesiology
100510(k) clearances
0PMA approvals
28recalls
Manufacturers
- Allied Healthcare Products, Inc. 9
- Pneupac , Ltd. 8
- Life Support Products, Inc. 8
- O-Two Systems Intl., Inc. 7
- Vortran Medical Technology 1, Inc. 6
- Life Corp. 5
- Impact Instrumentation, Inc. 5
- O-Two Medical Technologies, Inc. 5
- Smiths Medical International , Ltd. 3
- Thornhill Research, Inc. 3
- Mercury Medical 2
- Automedx, Inc. 2
- Ohmeda Medical 2
- Instrumentation Industries, Inc. 2
- Khi, Inc. 2
- International Biomedical 2
- Draegerwerk AG & CO Kgaa 1
- Neotronics Medical , Ltd. 1
- Hursch Ent., Inc. 1
- U.O. Equipment Co. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242769 | VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)BTL · Traditional | Draegerwerk AG & CO Kgaa | 04/04/2025SE |
| K221634 | Oxymag - Transport and Emergency VentilatorBTL · Traditional | Magnamed Tecnologia Medica S/A | 05/24/2023SE |
| K202219 | VORTRAN GO2VENT with PEEP ValveBTL · Traditional | Vortran Medical Technology 1, Inc. | 02/11/2021SE |
| K193191 | MEDUMAT Easy CPR, MEDUMAT Easy CPR with bagBTL · Traditional | Weinmann Emergency Medical Technology GmbH + Co.… | 11/20/2020SE |
| K182956 | Puffin Lite Infant Resuscitation SystemBTL · Special | International Biomedical | 01/18/2019SE |
| K173373 | SafeT T-Piece ResuscitatorBTL · Traditional | Ventlab, LLC | 11/16/2018SE |
| K161420 | Moves SLCBTL · Traditional | Thornhill Research, Inc. | 06/06/2017SE |
| K162968 | Vortran GO2VENTBTL · Traditional | Vortran Medical Technology 1, Inc. | 04/10/2017SE |
| K141595 | O-Two E700,O-TWO E600,O-TWO E500BTL · Traditional | O-Two Medical Technologies, Inc. | 03/16/2015SE |
| K142096 | T-Piece ResuscitatorBTL · Traditional | Mercury Medical | 10/17/2014SE |
| K140049 | Moves SLCBTL · Traditional | Thornhill Research, Inc. | 05/29/2014SE |
| K140707 | Lifeborne Infant ResuscitatorBTL · Traditional | International Biomedical | 05/28/2014SE |
| K131098 | Emergency Portable VentilatorBTL · Traditional | Allied Healthcare Products, Inc. | 04/09/2014SE |
| K132021 | Ahp 300, Emergency Portable VentilatorBTL · Traditional | Allied Healthcare Products, Inc. | 04/02/2014SE |
| K132759 | VentrainBTL · Traditional | Dolphys Medical B.V. | 03/26/2014SE |
| K131877 | Save II, Save II BasicBTL · Traditional | Automedx, Inc. | 03/21/2014SE |
| K123957 | Pneupac Parapac PlusBTL · Traditional | Smiths Medical International , Ltd. | 09/16/2013SE |
| K112783 | Manujet IIIBTL · Traditional | VBM Medizintechnik GmbH | 12/22/2011SE |
| K102542 | Resusci Flow; Resusci Flow 104BTL · Traditional | Atom Medical Corporation | 04/06/2011SE |
| K093862 | Carevent Handheld CPAP SystemBTL · Traditional | O-Two Medical Technologies, Inc. | 05/06/2010SE |
| K093913 | Mercury Medical T-Piece ResuscitatorBTL · Traditional | Mercury Medical, Inc. | 04/06/2010SE |
| K093261 | MovesBTL · Traditional | Thornhill Research, Inc. | 03/26/2010SE |
| K092085 | Ispira Resuscitation UnitBTL · Traditional | Neoforce Group, Inc. | 10/07/2009SE |
| K090356 | Emergency Portable Ventilator, Model EPV200BTL · Traditional | Allied Healthcare Products, Inc. | 05/20/2009SE |
| K083507 | Battery Pack for MCV100 and MCV200 Emergency VentilatorsBTL · Traditional | Allied Healthcare Products, Inc. | 05/18/2009SE |
| K083385 | Mass Casualty Ventilators, Models: MCV200 and MCV200-BBTL · Traditional | Allied Healthcare Products, Inc. | 05/14/2009SE |
| K081330 | Carevent Par (Public Access Resuscitator)BTL · Traditional | O-Two Medical Technologies, Inc. | 03/06/2009SE |
| K080063 | Mass Casualty Ventilator, Model MCV100BTL · Traditional | Allied Healthcare Products, Inc. | 08/15/2008SE |
| K080692 | Macs CPAP SystemBTL · Traditional | Airon Corporation | 06/20/2008SE |
| K073261 | Var MonitorBTL · Special | Vortran Medical Technology 1, Inc. | 05/23/2008SE |
| K072214 | Portable Ventilator, Model EPV-100BTL · Traditional | Allied Healthcare Products, Inc. | 03/06/2008SE |
| K071527 | Pneupac VR1 Air MixBTL · Traditional | Smiths Medical International , Ltd. | 10/04/2007SE |
| K071221 | Save-Simplified Automated Ventilator, Models: 550X10, 600X10 and 600X12BTL · Traditional | Automedx, Inc. | 09/06/2007SE |
| K070636 | Autovent 4000 with CPAPBTL · Traditional | Allied Healthcare Products, Inc. | 07/13/2007SE |
| K070120 | Autovent Model 4000BTL · Traditional | Allied Healthcare Products, Inc. | 05/03/2007SE |
| K070210 | Giraffe and Panda T- Piece Resuscitation SystemBTL · Traditional | Ohmeda Medical | 04/20/2007SE |
| K051476 | Uni-Vent Model 73XBTL · Traditional | Impact Instrumentation, Inc. | 10/28/2005SE |
| K051469 | Carevent Atv+ and Carevent MRIBTL · Traditional | O-Two Medical Technologies, Inc. | 09/28/2005SE |
| K051889 | Carevent Ca and DraBTL · Special | O-Two Medical Technologies, Inc. | 08/30/2005SE |
| K051322 | Pneupac Vri Standard, Model Vristdnus, Pneupac Vri Responder, Model VriresnusBTL · Traditional | Smiths Medical International , Ltd. | 08/05/2005SE |
| K043495 | BabypacBTL · Traditional | Smiths Medical International Ltd., Luton | 04/22/2005SE |
| K041473 | Var-Plus (Vortran Automatic Resuscitator), Model PCMBTL · Traditional | Vortran Medical Technology 1, Inc. | 07/15/2004SE |
| K040090 | Comppac 200HD; CS12 Power Supply (Aircraft/Vechile); PS11 Power Supply (Mains)BTL · Traditional | Pneupac , Ltd. | 05/27/2004SE |
| K032386 | Uni-Vent Model 730AEV (Automatic Emergency Ventilator)BTL · Traditional | Impact Instrumentation, Inc. | 03/26/2004SE |
| K030803 | Parapac 200D Transport, Model V200DBTL · Traditional | Pneupac , Ltd. | 09/29/2003SE |
| K021841 | Comppac Ventilator Models 200 & PS11 Power Supply/ChargerBTL · Traditional | Pneupac , Ltd. | 07/17/2003SE |
| K020899 | Parapac 200 Medic, Model P200, & Parapac 200D Medic, Model P200DBTL · Traditional | Pneupac , Ltd. | 12/13/2002SE |
| K021520 | Emt-CpapBTL · Traditional | Emergency Medical Techology | 07/15/2002SE |
| K001430 | Respirtech PRO-O2C, Model 2200 and Respirtech Pro, Model 2000BTL · Traditional | Vortran Medical Technology 1, Inc. | 07/05/2000SE |
| K991785 | Manual Jet Ventilator (with Regulator and Gauge), Manual Jet Ventilator (Without…BTL · Traditional | Instrumentation Industries, Inc. | 08/17/1999SE |
| K991195 | Carevent BLS, Carevent Bls+, Carevent Als, Carevent Als+, and Carevent AtvBTL · Special | O-Two Systems Intl., Inc. | 04/22/1999SE |
| K983857 | Autovent 1500BTL · Special | O-Two Systems Intl., Inc. | 11/04/1998SE |
| K983785 | Autovent 1000BTL · Special | O-Two Systems Intl., Inc. | 10/29/1998SE |
| K983705 | Emt ResuscitatorBTL · Special | O-Two Systems Intl., Inc. | 10/29/1998SE |
| K983643 | Genesis BLSBTL · Special | O-Two Systems Intl., Inc. | 10/29/1998SE |
| K982225 | Spiracle Technology-Bi-Flow Demand/Resuscitator Valve, Model 504BTL · Traditional | Spiracle Technology | 10/28/1998SE |
| K973975 | RespirtechproBTL · Traditional | Vortran Medical Technology 1, Inc. | 06/12/1998SE |
| K960515 | ParapacBTL · Traditional | Pneupac , Ltd. | 10/10/1996SE |
| K944349 | Oxylator EM-100BTL · Traditional | Cpr Medical Devices, Inc. | 04/17/1995SE |
| K951126 | Drager Medical Air CompressorBTL · Traditional | Drager, Inc. | 03/24/1995SE |
| K944397 | Bnos Microvent, Model Ac and Model AoBTL · Traditional | Racal Health & Safety, Inc. | 01/31/1995SESK |
| K941871 | Lspi Automatic Ventilator, Model AV3000-100BTL · Traditional | Life Support Products, Inc. | 01/09/1995SE |
| K941870 | Lspi Automatic Ventilator, Model AV2000-100BTL · Traditional | Life Support Products, Inc. | 01/09/1995SE |
| K931473 | Impact Model 753BTL · Traditional | Impact Instrumentation, Inc. | 12/30/1994SE |
| K924272 | Mediresp IIIBTL · Traditional | Medflow Corp., Inc. | 02/09/1994SE |
| K932200 | Lspi Automatic VentilatorBTL · Traditional | Life Support Products, Inc. | 11/24/1993SE |
| K932199 | Lspi Automatic Ventilator, Model AV3000BTL · Traditional | Life Support Products, Inc. | 11/24/1993SE |
| K932170 | Flynnr Genesis II A/C, A/O and IdlhBTL · Traditional | O-Two Systems Intl., Inc. | 10/25/1993SE |
| K920910 | Oxygen Powered Resuscitator for CPRBTL · Traditional | J. H. Emerson Co. | 01/12/1993SE |
| K921926 | Jet Ventilator/Jetting DeviceBTL · Traditional | Anesthesia Assoc., Inc. | 10/13/1992SE |
| K913039 | Fllynn(R) Genesis AcBTL · Traditional | O-Two Systems Intl., Inc. | 08/25/1992SE |
| K915564 | SpirosBTL · Traditional | Life Support Products, Inc. | 01/30/1992SE |
| K910699 | LIFE-02 (Non-Refillable Cylinder)BTL · Traditional | Life Corp. | 06/18/1991SE |
| K910435 | Life Oxygenpac 6/12 LPMBTL · Traditional | Life Corp. | 06/17/1991SE |
| K910434 | Life Oxygenpac for Trained Medical PersonnelBTL · Traditional | Life Corp. | 06/17/1991SE |
| K911261 | Era 2000ABTL · Traditional | Neotronics, Inc. | 05/31/1991SE |
| K904920 | Ambu Matic Automatic ResuscitatorBTL · Traditional | Ambu, Inc. | 05/28/1991SE |
| K910201 | Life O2BTL · Traditional | Life Corp. | 02/01/1991SE |
| K905697 | Powered Ventilator, Lever I/Ii, Battlefield UseBTL · Traditional | Impact Instrumentation, Inc. | 12/27/1990SE |
| K901846 | Ohmeda - Logic 07A Transport VentilatorBTL · Traditional | Ohmeda Medical | 08/08/1990SE |
| K895946 | Bivona Carden Intermittent Jetting DeviceBTL · Traditional | Bivona Medical Technologies | 01/09/1990SE |
| K892885 | Resubmitted RD1000 Neopuff Infant ResuscitatorBTL · Traditional | Fisher & Paykel Electronics , Ltd. | 10/06/1989SE |
| K884089 | Era 2000 Emergency ResuscitatorBTL · Traditional | Neotronics Medical , Ltd. | 12/20/1988SE |
| K882833 | The Berg Resuscitation ApparatusBTL · Traditional | Hursch Ent., Inc. | 08/19/1988SE |
| K870424 | LSP Automatic Ventilator, Model 456BTL · Traditional | Life Support Products, Inc. | 01/22/1988SE |
| K874656 | Automatic Ventilator AV2000BTL · Traditional | Life Support Products, Inc. | 01/19/1988SE |
| K863410 | Patient Valve with Air EntrainmentBTL · Traditional | Pneupac , Ltd. | 01/12/1987SE |
| K862830 | Models 2R and 3R Pneupac Ventilator/ResuscitatorBTL · Traditional | Pneupac , Ltd. | 10/15/1986SE |
| K862192 | Resuscitator Models 10400/10500/10600/10700/10800BTL · Traditional | U.O. Equipment Co. | 07/07/1986SE |
| K861272 | Impact Models 701, 702 and 703BTL · Traditional | Impact Instrumentation, Inc. | 05/20/1986SE |
| K860077 | SG-066 Oxygen Enrichment KitBTL · Traditional | Instrumentation Industries, Inc. | 02/18/1986SE |
| K855092 | Life Corp. Oxygen PacBTL · Traditional | Life Corp. | 01/21/1986SE |
| K853971 | Regulator-Inhalator SystemBTL · Traditional | Stephenson Industries, Inc. | 12/09/1985SE |
| K851337 | 502 Resuscitatory Inhalator ValveBTL · Traditional | Life Support Products, Inc. | 05/15/1985SE |
| K841893 | MaxamanBTL · Traditional | Cryo2 Corp. | 08/30/1984SE |
| K830404 | Rad ValveBTL · Traditional | Khi, Inc. | 03/17/1983SE |
| K800456 | Emergiency Resuscitator/Inhalor W/Aspir.BTL · Traditional | Khi, Inc. | 03/18/1980SE |
| K792453 | Pneupac Oxygen Therapy UnitBTL · Traditional | Pneupac , Ltd. | 02/05/1980SE |
| K780168 | Paramedic O2 KitBTL · Traditional | Pohlmann Rescue Products, Inc. | 04/18/1978SE |
| K771299 | Emergency Oxygen ResuscitatorBTL · Traditional | Fraser Sweatman, Inc. | 08/04/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0821-2025 Class I | Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part:…Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring… | Mercury Enterprises, Inc. dba Mercury Medical | 12/10/2024Open, Classified |
| Z-0004-2025 Class I | Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency…Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step. | Mercury Enterprises, Inc. dba Mercury Medical | 08/30/2024Open, Classified |
| Z-3091-2024 Class I | paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300NSmiths Medical became aware of an issue related to a potential for the patient outlet connector to… | Smiths Medical ASD Inc. | 05/31/2024Open, Classified |
| Z-3090-2024 Class I | paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310NSmiths Medical became aware of an issue related to a potential for the patient outlet connector to… | Smiths Medical ASD Inc. | 05/31/2024Open, Classified |
| Z-2974-2024 Class I | Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXXThere is a potential for inadvertent tidal volume knob movement from the original setting when set at high… | Smiths Medical ASD Inc. | 05/31/2024Open, Classified |
| Z-2973-2024 Class I | Pneupac paraPAC plus 300 ventilator kit, REF P300NXXThere is a potential for inadvertent tidal volume knob movement from the original setting when set at high… | Smiths Medical ASD Inc. | 05/31/2024Open, Classified |
| Z-1275-2024 Class I | smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUSWhen a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may… | Smiths Medical ASD Inc. | 02/07/2024Open, Classified |
| Z-1274-2024 Class I | smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUSWhen a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may… | Smiths Medical ASD Inc. | 02/07/2024Open, Classified |
| Z-0163-2022 Class III | Pneupac paraPac plus 300 ventilator kit, REF P300NGBTwo devices were labeled with the same serial number | Smiths Medical ASD Inc. | 07/15/2021Terminated |
| Z-2805-2020 Class II | PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients…While operating the machine in "Run" mode an unexcepted event may occur during the error-checking for… | Precision Valve & Automation,Inc | 06/26/2020Open, Classified |
| Z-0978-2019 Class I | e700 Automatic Transport Ventilator, Model Number 01EVE700There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly… | O-Two Medical Technologies, Inc. | 02/12/2019Terminated |
| Z-0977-2019 Class I | e600 Automatic Transport Ventilator, Model Number 01EVE600There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly… | O-Two Medical Technologies, Inc. | 02/12/2019Terminated |
| Z-0976-2019 Class I | e500 Automatic Transport Ventilator, Model Number 01EVE500There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly… | O-Two Medical Technologies, Inc. | 02/12/2019Terminated |
| Z-2092-2017 Class II | VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10…Vortran received a customer complaint that the spin-nut-DSS connector was assembled in the reverse direction… | Vortran Medical Technology 1, Inc | 04/20/2017Terminated |
| Z-2091-2017 Class II | VORTRAN Automatic Resuscitator, VARPlus; Model PTE-5002; Qty: 10 each Anesthesiology:…Vortran received a customer complaint that the spin-nut-DSS connector was assembled in the reverse direction… | Vortran Medical Technology 1, Inc | 04/20/2017Terminated |
| Z-0587-2016 Class I | MOVES System Lithium Polymer Batteries The MOVES System is a portable computer…Batteries found unresponsive after storage, not recognized by main device, and are perpetually enabled. | Thornhill Research Inc | 11/19/2015Terminated |
| Z-0586-2016 Class I | MOVES System, an emergency ventilator with suction, oxygen concentrator and…Batteries found unresponsive after storage, not recognized by main device, and are perpetually enabled. | Thornhill Research Inc | 11/19/2015Terminated |
| Z-0639-2016 Class II | Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece…Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit and… | Mercury Enterprises, Inc. dba Mercury Medical | 10/22/2015Terminated |
| Z-1440-2014 Class I | Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number:…The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted and the… | Draeger Medical Systems, Inc. | 03/05/2014Terminated |
| Z-0917-2014 Class II | Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628…Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to… | GE Healthcare | 12/12/2013Terminated |
| Z-0916-2014 Class II | Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001…Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to… | GE Healthcare | 12/12/2013Terminated |
| Z-1072-2014 Class I | GE Healthcare - Giraffe and Panda iRes Infant Warmer Product Usage: The infant radiant…Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during… | GE Healthcare, LLC | 10/01/2013Terminated |
| Z-1070-2014 Class I | GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone…Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during… | GE Healthcare, LLC | 10/01/2013Terminated |
| Z-0748-2013 Class I | GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation…Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during… | GE Healthcare, LLC | 10/15/2012Terminated |
| Z-1125-2013 Class II | Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR…Firm initiated an update to Directions for Use necessitating replacement of previously distributed… | Instrumentation Industries Inc | 09/07/2012Terminated |
| Z-0606-2013 Class I | GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient…Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak Inspiratory… | GE Healthcare, LLC | 06/26/2012Terminated |
| Z-0870-2012 | Model 73X Uni-Vent Product Usage: Intended for use at mass casualty incidents.A piece of internal tubing in the 73X portable ventilator is of incorrect specifications for the device. | Impact Instrumentation, Inc. | 11/04/2011Terminated |
| Z-0991-2007 | Pneupac VR1 Standard and VR1 Responder is a hand held portable, time cycled, gas…Smiths Medical is conducting a recall of 93 Pneupac VR1 Emergency & Transport Ventilators following the… | Smiths Medical PM, Inc. | 05/16/2007Terminated |