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Panels › Anesthesiology › Product code BTL · Class 2

Ventilator, Emergency, Powered (Resuscitator)

Regulation 868.5925

0510(k)s in 12 months (100 all time)
0recalls in 12 months (29 all time)
27recalls that name a 510(k)
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Top companies in BTL

Decided510(k)Device and applicantCode
Apr 4, 2025K242769VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)
Draegerwerk AG & CO Kgaa, DE
BTL
May 24, 2023K221634Oxymag - Transport and Emergency Ventilator
Magnamed Tecnologia Medica S/A, BR
BTL
Feb 11, 2021K202219VORTRAN GO2VENT with PEEP Valve
Vortran Medical Technology 1, Inc.
BTL
Nov 20, 2020K193191MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag
Weinmann Emergency Medical Technology GmbH + Co. KG, DE
BTL
Jan 18, 2019K182956Puffin Lite Infant Resuscitation System
International Biomedical
BTL
Nov 16, 2018K173373SafeT T-Piece Resuscitator
Ventlab, LLC
BTL
Jun 6, 2017K161420MOVES SLC
Thornhill Research, Inc., CA
BTL
Apr 10, 2017K162968VORTRAN GO2VENT
Vortran Medical Technology 1, Inc.
BTL
Mar 16, 2015K141595O-TWO E700,O-TWO E600,O-TWO E500
O-Two Medical Technologies, Inc., CA
BTL
Oct 17, 2014K142096T-PIECE RESUSCITATOR
Mercury Medical
BTL
May 29, 2014K140049MOVES SLC
Thornhill Research, Inc., CA
BTL
May 28, 2014K140707LIFEBORNE INFANT RESUSCITATOR
International Biomedical
BTL
Apr 9, 2014K131098EMERGENCY PORTABLE VENTILATOR
Allied Healthcare Products, Inc.
BTL
Apr 2, 2014K132021AHP 300, EMERGENCY PORTABLE VENTILATOR
Allied Healthcare Products, Inc.
BTL
Mar 26, 2014K132759VENTRAIN
Dolphys Medical B.V., NL
BTL
Mar 21, 2014K131877SAVE II, SAVE II BASIC
Automedx, Inc.
BTL
Sep 16, 2013K123957PNEUPAC PARAPAC PLUS
Smiths Medical International , Ltd., GB
BTL
Dec 22, 2011K112783MANUJET III
VBM Medizintechnik GmbH, DE
BTL
Apr 6, 2011K102542RESUSCI FLOW; RESUSCI FLOW 104
Atom Medical Corporation
BTL
May 6, 2010K093862CAREVENT HANDHELD CPAP SYSTEM
O-Two Medical Technologies, Inc., CA
BTL
Apr 6, 2010K093913MERCURY MEDICAL T-PIECE RESUSCITATOR
Mercury Medical, Inc.
BTL
Mar 26, 2010K093261MOVES
Thornhill Research, Inc., CA
BTL
Oct 7, 2009K092085ISPIRA RESUSCITATION UNIT
Neoforce Group, Inc.
BTL
May 20, 2009K090356EMERGENCY PORTABLE VENTILATOR, MODEL EPV200
Allied Healthcare Products, Inc.
BTL
May 18, 2009K083507BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS
Allied Healthcare Products, Inc.
BTL
May 14, 2009K083385MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B
Allied Healthcare Products, Inc.
BTL
Mar 6, 2009K081330CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)
O-Two Medical Technologies, Inc.
BTL
Aug 15, 2008K080063MASS CASUALTY VENTILATOR, MODEL MCV100
Allied Healthcare Products, Inc.
BTL
Jun 20, 2008K080692MACS CPAP SYSTEM
Airon Corporation
BTL
May 23, 2008K073261VAR MONITOR
Vortran Medical Technology 1, Inc.
BTL
Mar 6, 2008K072214PORTABLE VENTILATOR, MODEL EPV-100
Allied Healthcare Products, Inc.
BTL
Oct 4, 2007K071527PNEUPAC VR1 AIR MIX
Smiths Medical International , Ltd.
BTL
Sep 6, 2007K071221SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12
Automedx, Inc.
BTL
Jul 13, 2007K070636AUTOVENT 4000 WITH CPAP
Allied Healthcare Products, Inc.
BTL
May 3, 2007K070120AUTOVENT MODEL 4000
Allied Healthcare Products, Inc.
BTL
Apr 20, 2007K070210GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM
Ohmeda Medical
BTL
Oct 28, 2005K051476UNI-VENT MODEL 73X
Impact Instrumentation, Inc.
BTL
Sep 28, 2005K051469CAREVENT ATV+ AND CAREVENT MRI
O-Two Medical Technologies, Inc., CA
BTL
Aug 30, 2005K051889CAREVENT CA AND DRA
O-Two Medical Technologies, Inc., CA
BTL
Aug 5, 2005K051322PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS
Smiths Medical International , Ltd.
BTL
Apr 22, 2005K043495BABYPAC
Smiths Medical International Ltd., Luton
BTL
Jul 15, 2004K041473VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM
Vortran Medical Technology 1, Inc.
BTL
May 27, 2004K040090COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 POWER SUPPLY (MAINS)
Pneupac , Ltd.
BTL
Mar 26, 2004K032386UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)
Impact Instrumentation, Inc.
BTL
Sep 29, 2003K030803PARAPAC 200D TRANSPORT, MODEL V200D
Pneupac , Ltd.
BTL
Jul 17, 2003K021841COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER
Pneupac , Ltd.
BTL
Dec 13, 2002K020899PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200D
Pneupac , Ltd.
BTL
Jul 15, 2002K021520EMT-CPAP
Emergency Medical Techology
BTL
Jul 5, 2000K001430RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000
Vortran Medical Technology 1, Inc.
BTL
Aug 17, 1999K991785MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR
Instrumentation Industries, Inc.
BTL

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