Atlas FDA

BTL

100 FDA 510(k) clearances · Product code

128 daysmedian time to decision
352 days90th percentile
100clearances measured

FDA profile

Official device name
Ventilator, Emergency, Powered (Resuscitator)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5925
Medical specialty
Anesthesiology
Flags
Life-sustaining
Adverse events (MAUDE)
2021: 506 · 2022: 755 · 2023: 731 · 2024: 667 · 2025: 168 · 2026: 62
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) (K242769)Draegerwerk AG & CO Kgaa2025-04-04
Oxymag - Transport and Emergency Ventilator (K221634)Magnamed Tecnologia Medica S/A2023-05-24
VORTRAN GO2VENT with PEEP Valve (K202219)Vortran Medical Technology 1, Inc.2021-02-11
MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag (K193191)Weinmann Emergency Medical Technology GmbH + Co. KG2020-11-20
Puffin Lite Infant Resuscitation System (K182956)International Biomedical2019-01-18
SafeT T-Piece Resuscitator (K173373)Ventlab, LLC2018-11-16
MOVES SLC (K161420)Thornhill Research, Inc.2017-06-06
VORTRAN GO2VENT (K162968)Vortran Medical Technology 1, Inc.2017-04-10
O-TWO E700,O-TWO E600,O-TWO E500 (K141595)O-Two Medical Technologies, Inc.2015-03-16
T-PIECE RESUSCITATOR (K142096)Mercury Medical2014-10-17
MOVES SLC (K140049)Thornhill Research, Inc.2014-05-29
LIFEBORNE INFANT RESUSCITATOR (K140707)International Biomedical2014-05-28
EMERGENCY PORTABLE VENTILATOR (K131098)Allied Healthcare Products, Inc.2014-04-09
AHP 300, EMERGENCY PORTABLE VENTILATOR (K132021)Allied Healthcare Products, Inc.2014-04-02
VENTRAIN (K132759)Dolphys Medical B.V.2014-03-26
SAVE II, SAVE II BASIC (K131877)Automedx, Inc.2014-03-21
PNEUPAC PARAPAC PLUS (K123957)Smiths Medical International , Ltd.2013-09-16
MANUJET III (K112783)VBM Medizintechnik GmbH2011-12-22
RESUSCI FLOW; RESUSCI FLOW 104 (K102542)Atom Medical Corporation2011-04-06
CAREVENT HANDHELD CPAP SYSTEM (K093862)O-Two Medical Technologies, Inc.2010-05-06
MERCURY MEDICAL T-PIECE RESUSCITATOR (K093913)Mercury Medical, Inc.2010-04-06
MOVES (K093261)Thornhill Research, Inc.2010-03-26
ISPIRA RESUSCITATION UNIT (K092085)Neoforce Group, Inc.2009-10-07
EMERGENCY PORTABLE VENTILATOR, MODEL EPV200 (K090356)Allied Healthcare Products, Inc.2009-05-20
BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS (K083507)Allied Healthcare Products, Inc.2009-05-18
MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B (K083385)Allied Healthcare Products, Inc.2009-05-14
CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR) (K081330)O-Two Medical Technologies, Inc.2009-03-06
MASS CASUALTY VENTILATOR, MODEL MCV100 (K080063)Allied Healthcare Products, Inc.2008-08-15
MACS CPAP SYSTEM (K080692)Airon Corporation2008-06-20
VAR MONITOR (K073261)Vortran Medical Technology 1, Inc.2008-05-23
PORTABLE VENTILATOR, MODEL EPV-100 (K072214)Allied Healthcare Products, Inc.2008-03-06
PNEUPAC VR1 AIR MIX (K071527)Smiths Medical International , Ltd.2007-10-04
SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12 (K071221)Automedx, Inc.2007-09-06
AUTOVENT 4000 WITH CPAP (K070636)Allied Healthcare Products, Inc.2007-07-13
AUTOVENT MODEL 4000 (K070120)Allied Healthcare Products, Inc.2007-05-03
GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM (K070210)Ohmeda Medical2007-04-20
UNI-VENT MODEL 73X (K051476)Impact Instrumentation, Inc.2005-10-28
CAREVENT ATV+ AND CAREVENT MRI (K051469)O-Two Medical Technologies, Inc.2005-09-28
CAREVENT CA AND DRA (K051889)O-Two Medical Technologies, Inc.2005-08-30
PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS (K051322)Smiths Medical International , Ltd.2005-08-05
BABYPAC (K043495)Smiths Medical International Ltd., Luton2005-04-22
VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM (K041473)Vortran Medical Technology 1, Inc.2004-07-15
COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 POWER SUPPLY (MAINS) (K040090)Pneupac , Ltd.2004-05-27
UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR) (K032386)Impact Instrumentation, Inc.2004-03-26
PARAPAC 200D TRANSPORT, MODEL V200D (K030803)Pneupac , Ltd.2003-09-29
COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER (K021841)Pneupac , Ltd.2003-07-17
PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200D (K020899)Pneupac , Ltd.2002-12-13
EMT-CPAP (K021520)Emergency Medical Techology2002-07-15
RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000 (K001430)Vortran Medical Technology 1, Inc.2000-07-05
MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR (K991785)Instrumentation Industries, Inc.1999-08-17
CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV (K991195)O-Two Systems Intl., Inc.1999-04-22
AUTOVENT 1500 (K983857)O-Two Systems Intl., Inc.1998-11-04
AUTOVENT 1000 (K983785)O-Two Systems Intl., Inc.1998-10-29
GENESIS BLS (K983643)O-Two Systems Intl., Inc.1998-10-29
EMT RESUSCITATOR (K983705)O-Two Systems Intl., Inc.1998-10-29
SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504 (K982225)Spiracle Technology1998-10-28
RESPIRTECHPRO (K973975)Vortran Medical Technology 1, Inc.1998-06-12
PARAPAC (K960515)Pneupac , Ltd.1996-10-10
OXYLATOR EM-100 (K944349)Cpr Medical Devices, Inc.1995-04-17
DRAGER MEDICAL AIR COMPRESSOR (K951126)Drager, Inc.1995-03-24
BNOS MICROVENT, MODEL AC AND MODEL AO (K944397)Racal Health & Safety, Inc.1995-01-31
LSPI AUTOMATIC VENTILATOR, MODEL AV3000-100 (K941871)Life Support Products, Inc.1995-01-09
LSPI AUTOMATIC VENTILATOR, MODEL AV2000-100 (K941870)Life Support Products, Inc.1995-01-09
IMPACT MODEL 753 (K931473)Impact Instrumentation, Inc.1994-12-30
MEDIRESP III (K924272)Medflow Corp., Inc.1994-02-09
LSPI AUTOMATIC VENTILATOR, MODEL AV3000 (K932199)Life Support Products, Inc.1993-11-24
LSPI AUTOMATIC VENTILATOR (K932200)Life Support Products, Inc.1993-11-24
FLYNNR GENESIS II A/C, A/O AND IDLH (K932170)O-Two Systems Intl., Inc.1993-10-25
OXYGEN POWERED RESUSCITATOR FOR CPR (K920910)J. H. Emerson Co.1993-01-12
JET VENTILATOR/JETTING DEVICE (K921926)Anesthesia Assoc., Inc.1992-10-13
FLLYNN(R) GENESIS AC (K913039)O-Two Systems Intl., Inc.1992-08-25
SPIROS (K915564)Life Support Products, Inc.1992-01-30
LIFE-02 (NON-REFILLABLE CYLINDER) (K910699)Life Corp.1991-06-18
LIFE OXYGENPAC FOR TRAINED MEDICAL PERSONNEL (K910434)Life Corp.1991-06-17
LIFE OXYGENPAC 6/12 LPM (K910435)Life Corp.1991-06-17
ERA 2000A (K911261)Neotronics, Inc.1991-05-31
AMBU MATIC AUTOMATIC RESUSCITATOR (K904920)Ambu, Inc.1991-05-28
LIFE O2 (K910201)Life Corp.1991-02-01
POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE (K905697)Impact Instrumentation, Inc.1990-12-27
OHMEDA - LOGIC 07A TRANSPORT VENTILATOR (K901846)Ohmeda Medical1990-08-08
BIVONA CARDEN INTERMITTENT JETTING DEVICE (K895946)Bivona Medical Technologies1990-01-09
RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR (K892885)Fisher & Paykel Electronics , Ltd.1989-10-06
ERA 2000 EMERGENCY RESUSCITATOR (K884089)Neotronics Medical , Ltd.1988-12-20
THE BERG RESUSCITATION APPARATUS (K882833)Hursch Ent., Inc.1988-08-19
LSP AUTOMATIC VENTILATOR, MODEL 456 (K870424)Life Support Products, Inc.1988-01-22
AUTOMATIC VENTILATOR AV2000 (K874656)Life Support Products, Inc.1988-01-19
PATIENT VALVE WITH AIR ENTRAINMENT (K863410)Pneupac , Ltd.1987-01-12
MODELS 2R AND 3R PNEUPAC VENTILATOR/RESUSCITATOR (K862830)Pneupac , Ltd.1986-10-15
RESUSCITATOR MODELS 10400/10500/10600/10700/10800 (K862192)U.O. Equipment Co.1986-07-07
IMPACT MODELS 701, 702 AND 703 (K861272)Impact Instrumentation, Inc.1986-05-20
SG-066 OXYGEN ENRICHMENT KIT (K860077)Instrumentation Industries, Inc.1986-02-18
LIFE CORP. OXYGEN PAC (K855092)Life Corp.1986-01-21
REGULATOR-INHALATOR SYSTEM (K853971)Stephenson Industries, Inc.1985-12-09
502 RESUSCITATORY INHALATOR VALVE (K851337)Life Support Products, Inc.1985-05-15
MAXAMAN (K841893)Cryo2 Corp.1984-08-30
RAD VALVE (K830404)Khi, Inc.1983-03-17
EMERGIENCY RESUSCITATOR/INHALOR W/ASPIR. (K800456)Khi, Inc.1980-03-18
PNEUPAC OXYGEN THERAPY UNIT (K792453)Pneupac , Ltd.1980-02-05
PARAMEDIC O2 KIT (K780168)Pohlmann Rescue Products, Inc.1978-04-18
EMERGENCY OXYGEN RESUSCITATOR (K771299)Fraser Sweatman, Inc.1977-08-04

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