BTL · Ventilator, Emergency, Powered (Resuscitator)
Anesthesiology · 21 CFR 868.5925 · Class 2
Overview
| Product Code | BTL |
|---|---|
| Device Name | Ventilator, Emergency, Powered (Resuscitator) |
| Regulation | 21 CFR 868.5925 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| Life-Sustaining | Yes |
Identification
A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.
Classification Rationale
Class II (performance standards).
Cleared Devices (100)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242769 | VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) | Draegerwerk AG & CO Kgaa | Apr 4, 2025 | SESE |
| K221634 | Oxymag - Transport and Emergency Ventilator | Magnamed Tecnologia Medica S/A | May 24, 2023 | SESE |
| K202219 | VORTRAN GO2VENT with PEEP Valve | Vortran Medical Technology 1, Inc. | Feb 11, 2021 | SESE |
| K193191 | MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag | Weinmann Emergency Medical Technology GmbH + Co. KG | Nov 20, 2020 | SESE |
| K182956 | Puffin Lite Infant Resuscitation System | International Biomedical | Jan 18, 2019 | SESE |
| K173373 | SafeT T-Piece Resuscitator | Ventlab, LLC | Nov 16, 2018 | SESE |
| K161420 | MOVES SLC | Thornhill Research, Inc. | Jun 6, 2017 | SESE |
| K162968 | VORTRAN GO2VENT | Vortran Medical Technology 1, Inc. | Apr 10, 2017 | SESE |
| K141595 | O-TWO E700,O-TWO E600,O-TWO E500 | O-Two Medical Technologies, Inc. | Mar 16, 2015 | SESE |
| K142096 | T-PIECE RESUSCITATOR | Mercury Medical | Oct 17, 2014 | SESE |
| K140049 | MOVES SLC | Thornhill Research, Inc. | May 29, 2014 | SESE |
| K140707 | LIFEBORNE INFANT RESUSCITATOR | International Biomedical | May 28, 2014 | SESE |
| K131098 | EMERGENCY PORTABLE VENTILATOR | Allied Healthcare Products, Inc. | Apr 9, 2014 | SESE |
| K132021 | AHP 300, EMERGENCY PORTABLE VENTILATOR | Allied Healthcare Products, Inc. | Apr 2, 2014 | SESE |
| K132759 | VENTRAIN | Dolphys Medical B.V. | Mar 26, 2014 | SESE |
| K131877 | SAVE II, SAVE II BASIC | Automedx, Inc. | Mar 21, 2014 | SESE |
| K123957 | PNEUPAC PARAPAC PLUS | Smiths Medical International , Ltd. | Sep 16, 2013 | SESE |
| K112783 | MANUJET III | VBM Medizintechnik GmbH | Dec 22, 2011 | SESE |
| K102542 | RESUSCI FLOW; RESUSCI FLOW 104 | Atom Medical Corporation | Apr 6, 2011 | SESE |
| K093862 | CAREVENT HANDHELD CPAP SYSTEM | O-Two Medical Technologies, Inc. | May 6, 2010 | SESE |
| K093913 | MERCURY MEDICAL T-PIECE RESUSCITATOR | Mercury Medical, Inc. | Apr 6, 2010 | SESE |
| K093261 | MOVES | Thornhill Research, Inc. | Mar 26, 2010 | SESE |
| K092085 | ISPIRA RESUSCITATION UNIT | Neoforce Group, Inc. | Oct 7, 2009 | SESE |
| K090356 | EMERGENCY PORTABLE VENTILATOR, MODEL EPV200 | Allied Healthcare Products, Inc. | May 20, 2009 | SESE |
| K083507 | BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS | Allied Healthcare Products, Inc. | May 18, 2009 | SESE |
| K083385 | MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B | Allied Healthcare Products, Inc. | May 14, 2009 | SESE |
| K081330 | CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR) | O-Two Medical Technologies, Inc. | Mar 6, 2009 | SESE |
| K080063 | MASS CASUALTY VENTILATOR, MODEL MCV100 | Allied Healthcare Products, Inc. | Aug 15, 2008 | SESE |
| K080692 | MACS CPAP SYSTEM | Airon Corporation | Jun 20, 2008 | SESE |
| K073261 | VAR MONITOR | Vortran Medical Technology 1, Inc. | May 23, 2008 | SESE |
| K072214 | PORTABLE VENTILATOR, MODEL EPV-100 | Allied Healthcare Products, Inc. | Mar 6, 2008 | SESE |
| K071527 | PNEUPAC VR1 AIR MIX | Smiths Medical International , Ltd. | Oct 4, 2007 | SESE |
| K071221 | SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12 | Automedx, Inc. | Sep 6, 2007 | SESE |
| K070636 | AUTOVENT 4000 WITH CPAP | Allied Healthcare Products, Inc. | Jul 13, 2007 | SESE |
| K070120 | AUTOVENT MODEL 4000 | Allied Healthcare Products, Inc. | May 3, 2007 | SESE |
| K070210 | GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM | Ohmeda Medical | Apr 20, 2007 | SESE |
| K051476 | UNI-VENT MODEL 73X | Impact Instrumentation, Inc. | Oct 28, 2005 | SESE |
| K051469 | CAREVENT ATV+ AND CAREVENT MRI | O-Two Medical Technologies, Inc. | Sep 28, 2005 | SESE |
| K051889 | CAREVENT CA AND DRA | O-Two Medical Technologies, Inc. | Aug 30, 2005 | SESE |
| K051322 | PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS | Smiths Medical International , Ltd. | Aug 5, 2005 | SESE |
| K043495 | BABYPAC | Smiths Medical International Ltd., Luton | Apr 22, 2005 | SESE |
| K041473 | VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM | Vortran Medical Technology 1, Inc. | Jul 15, 2004 | SESE |
| K040090 | COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 POWER SUPPLY (MAINS) | Pneupac , Ltd. | May 27, 2004 | SESE |
| K032386 | UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR) | Impact Instrumentation, Inc. | Mar 26, 2004 | SESE |
| K030803 | PARAPAC 200D TRANSPORT, MODEL V200D | Pneupac , Ltd. | Sep 29, 2003 | SESE |
| K021841 | COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER | Pneupac , Ltd. | Jul 17, 2003 | SESE |
| K020899 | PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200D | Pneupac , Ltd. | Dec 13, 2002 | SESE |
| K021520 | EMT-CPAP | Emergency Medical Techology | Jul 15, 2002 | SESE |
| K001430 | RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000 | Vortran Medical Technology 1, Inc. | Jul 5, 2000 | SESE |
| K991785 | MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR | Instrumentation Industries, Inc. | Aug 17, 1999 | SESE |
| K991195 | CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV | O-Two Systems Intl., Inc. | Apr 22, 1999 | SESE |
| K983857 | AUTOVENT 1500 | O-Two Systems Intl., Inc. | Nov 4, 1998 | SESE |
| K983785 | AUTOVENT 1000 | O-Two Systems Intl., Inc. | Oct 29, 1998 | SESE |
| K983705 | EMT RESUSCITATOR | O-Two Systems Intl., Inc. | Oct 29, 1998 | SESE |
| K983643 | GENESIS BLS | O-Two Systems Intl., Inc. | Oct 29, 1998 | SESE |
| K982225 | SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504 | Spiracle Technology | Oct 28, 1998 | SESE |
| K973975 | RESPIRTECHPRO | Vortran Medical Technology 1, Inc. | Jun 12, 1998 | SESE |
| K960515 | PARAPAC | Pneupac , Ltd. | Oct 10, 1996 | SESE |
| K944349 | OXYLATOR EM-100 | Cpr Medical Devices, Inc. | Apr 17, 1995 | SESE |
| K951126 | DRAGER MEDICAL AIR COMPRESSOR | Drager, Inc. | Mar 24, 1995 | SESE |
| K944397 | BNOS MICROVENT, MODEL AC AND MODEL AO | Racal Health & Safety, Inc. | Jan 31, 1995 | SESK |
| K941871 | LSPI AUTOMATIC VENTILATOR, MODEL AV3000-100 | Life Support Products, Inc. | Jan 9, 1995 | SESE |
| K941870 | LSPI AUTOMATIC VENTILATOR, MODEL AV2000-100 | Life Support Products, Inc. | Jan 9, 1995 | SESE |
| K931473 | IMPACT MODEL 753 | Impact Instrumentation, Inc. | Dec 30, 1994 | SESE |
| K924272 | MEDIRESP III | Medflow Corp., Inc. | Feb 9, 1994 | SESE |
| K932200 | LSPI AUTOMATIC VENTILATOR | Life Support Products, Inc. | Nov 24, 1993 | SESE |
| K932199 | LSPI AUTOMATIC VENTILATOR, MODEL AV3000 | Life Support Products, Inc. | Nov 24, 1993 | SESE |
| K932170 | FLYNNR GENESIS II A/C, A/O AND IDLH | O-Two Systems Intl., Inc. | Oct 25, 1993 | SESE |
| K920910 | OXYGEN POWERED RESUSCITATOR FOR CPR | J. H. Emerson Co. | Jan 12, 1993 | SESE |
| K921926 | JET VENTILATOR/JETTING DEVICE | Anesthesia Assoc., Inc. | Oct 13, 1992 | SESE |
| K913039 | FLLYNN(R) GENESIS AC | O-Two Systems Intl., Inc. | Aug 25, 1992 | SESE |
| K915564 | SPIROS | Life Support Products, Inc. | Jan 30, 1992 | SESE |
| K910699 | LIFE-02 (NON-REFILLABLE CYLINDER) | Life Corp. | Jun 18, 1991 | SESE |
| K910435 | LIFE OXYGENPAC 6/12 LPM | Life Corp. | Jun 17, 1991 | SESE |
| K910434 | LIFE OXYGENPAC FOR TRAINED MEDICAL PERSONNEL | Life Corp. | Jun 17, 1991 | SESE |
| K911261 | ERA 2000A | Neotronics, Inc. | May 31, 1991 | SESE |
| K904920 | AMBU MATIC AUTOMATIC RESUSCITATOR | Ambu, Inc. | May 28, 1991 | SESE |
| K910201 | LIFE O2 | Life Corp. | Feb 1, 1991 | SESE |
| K905697 | POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE | Impact Instrumentation, Inc. | Dec 27, 1990 | SESE |
| K901846 | OHMEDA - LOGIC 07A TRANSPORT VENTILATOR | Ohmeda Medical | Aug 8, 1990 | SESE |
| K895946 | BIVONA CARDEN INTERMITTENT JETTING DEVICE | Bivona Medical Technologies | Jan 9, 1990 | SESE |
| K892885 | RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR | Fisher & Paykel Electronics , Ltd. | Oct 6, 1989 | SESE |
| K884089 | ERA 2000 EMERGENCY RESUSCITATOR | Neotronics Medical , Ltd. | Dec 20, 1988 | SESE |
| K882833 | THE BERG RESUSCITATION APPARATUS | Hursch Ent., Inc. | Aug 19, 1988 | SESE |
| K870424 | LSP AUTOMATIC VENTILATOR, MODEL 456 | Life Support Products, Inc. | Jan 22, 1988 | SESE |
| K874656 | AUTOMATIC VENTILATOR AV2000 | Life Support Products, Inc. | Jan 19, 1988 | SESE |
| K863410 | PATIENT VALVE WITH AIR ENTRAINMENT | Pneupac , Ltd. | Jan 12, 1987 | SESE |
| K862830 | MODELS 2R AND 3R PNEUPAC VENTILATOR/RESUSCITATOR | Pneupac , Ltd. | Oct 15, 1986 | SESE |
| K862192 | RESUSCITATOR MODELS 10400/10500/10600/10700/10800 | U.O. Equipment Co. | Jul 7, 1986 | SESE |
| K861272 | IMPACT MODELS 701, 702 AND 703 | Impact Instrumentation, Inc. | May 20, 1986 | SESE |
| K860077 | SG-066 OXYGEN ENRICHMENT KIT | Instrumentation Industries, Inc. | Feb 18, 1986 | SESE |
| K855092 | LIFE CORP. OXYGEN PAC | Life Corp. | Jan 21, 1986 | SESE |
| K853971 | REGULATOR-INHALATOR SYSTEM | Stephenson Industries, Inc. | Dec 9, 1985 | SESE |
| K851337 | 502 RESUSCITATORY INHALATOR VALVE | Life Support Products, Inc. | May 15, 1985 | SESE |
| K841893 | MAXAMAN | Cryo2 Corp. | Aug 30, 1984 | SESE |
| K830404 | RAD VALVE | Khi, Inc. | Mar 17, 1983 | SESE |
| K800456 | EMERGIENCY RESUSCITATOR/INHALOR W/ASPIR. | Khi, Inc. | Mar 18, 1980 | SESE |
| K792453 | PNEUPAC OXYGEN THERAPY UNIT | Pneupac , Ltd. | Feb 5, 1980 | SESE |
| K780168 | PARAMEDIC O2 KIT | Pohlmann Rescue Products, Inc. | Apr 18, 1978 | SESE |
| K771299 | EMERGENCY OXYGEN RESUSCITATOR | Fraser Sweatman, Inc. | Aug 4, 1977 | SESE |
Top Applicants
- Allied Healthcare Products, Inc. — 9 clearances
- Pneupac , Ltd. — 8 clearances
- Life Support Products, Inc. — 8 clearances
- O-Two Systems Intl., Inc. — 7 clearances
- Vortran Medical Technology 1, Inc. — 6 clearances
