Product Code: BTL FDA class 2 21 CFR 868.5925

Ventilator, Emergency, Powered (Resuscitator)

Anesthesiology

The Ventilator, Emergency, Powered (Resuscitator) is an electrically or pneumatically powered device used in emergency situations to provide artificial ventilation to patients who are not breathing adequately, often in prehospital or critical care settings. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BTL, regulated under 21 CFR 868.5925 in the Anesthesiology specialty. This device is designated as life-sustaining or life-supporting.

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510(k)s

100

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: BTL
Device Class: FDA class 2
Regulation Number: 868.5925
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 100 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K242769	VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)	Apr 04, 2025	Substantially Equivalent	Draegerwerk AG & CO Kgaa
K221634	Oxymag - Transport and Emergency Ventilator	May 24, 2023	Substantially Equivalent	Magnamed Tecnologia Medica S/A
K202219	VORTRAN GO2VENT with PEEP Valve	Feb 11, 2021	Substantially Equivalent	Vortran Medical Technology 1, Inc.
K193191	MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag	Nov 20, 2020	Substantially Equivalent	Weinmann Emergency Medical Technology GmbH + Co. KG
K182956	Puffin Lite Infant Resuscitation System	Jan 18, 2019	Substantially Equivalent	International Biomedical
K173373	SafeT T-Piece Resuscitator	Nov 16, 2018	Substantially Equivalent	Ventlab, LLC
K161420	MOVES SLC	Jun 06, 2017	Substantially Equivalent	Thornhill Research, Inc.
K162968	VORTRAN GO2VENT	Apr 10, 2017	Substantially Equivalent	Vortran Medical Technology 1, Inc.
K141595	O-TWO E700,O-TWO E600,O-TWO E500	Mar 16, 2015	Substantially Equivalent	O-Two Medical Technologies, Inc.
K142096	T-PIECE RESUSCITATOR	Oct 17, 2014	Substantially Equivalent	Mercury Medical
K140049	MOVES SLC	May 29, 2014	Substantially Equivalent	Thornhill Research, Inc.
K140707	LIFEBORNE INFANT RESUSCITATOR	May 28, 2014	Substantially Equivalent	International Biomedical
K131098	EMERGENCY PORTABLE VENTILATOR	Apr 09, 2014	Substantially Equivalent	Allied Healthcare Products, Inc.
K132021	AHP 300, EMERGENCY PORTABLE VENTILATOR	Apr 02, 2014	Substantially Equivalent	Allied Healthcare Products, Inc.
K132759	VENTRAIN	Mar 26, 2014	Substantially Equivalent	Dolphys Medical B.V.
K131877	SAVE II, SAVE II BASIC	Mar 21, 2014	Substantially Equivalent	Automedx, Inc.
K123957	PNEUPAC PARAPAC PLUS	Sep 16, 2013	Substantially Equivalent	Smiths Medical International , Ltd.
K112783	MANUJET III	Dec 22, 2011	Substantially Equivalent	VBM Medizintechnik GmbH
K102542	RESUSCI FLOW; RESUSCI FLOW 104	Apr 06, 2011	Substantially Equivalent	Atom Medical Corporation
K093862	CAREVENT HANDHELD CPAP SYSTEM	May 06, 2010	Substantially Equivalent	O-Two Medical Technologies, Inc.
K093913	MERCURY MEDICAL T-PIECE RESUSCITATOR	Apr 06, 2010	Substantially Equivalent	Mercury Medical, Inc.
K093261	MOVES	Mar 26, 2010	Substantially Equivalent	Thornhill Research, Inc.
K092085	ISPIRA RESUSCITATION UNIT	Oct 07, 2009	Substantially Equivalent	Neoforce Group, Inc.
K090356	EMERGENCY PORTABLE VENTILATOR, MODEL EPV200	May 20, 2009	Substantially Equivalent	Allied Healthcare Products, Inc.
K083507	BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS	May 18, 2009	Substantially Equivalent	Allied Healthcare Products, Inc.
K083385	MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B	May 14, 2009	Substantially Equivalent	Allied Healthcare Products, Inc.
K081330	CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)	Mar 06, 2009	Substantially Equivalent	O-Two Medical Technologies, Inc.
K080063	MASS CASUALTY VENTILATOR, MODEL MCV100	Aug 15, 2008	Substantially Equivalent	Allied Healthcare Products, Inc.
K080692	MACS CPAP SYSTEM	Jun 20, 2008	Substantially Equivalent	Airon Corporation
K073261	VAR MONITOR	May 23, 2008	Substantially Equivalent	Vortran Medical Technology 1, Inc.
K072214	PORTABLE VENTILATOR, MODEL EPV-100	Mar 06, 2008	Substantially Equivalent	Allied Healthcare Products, Inc.
K071527	PNEUPAC VR1 AIR MIX	Oct 04, 2007	Substantially Equivalent	Smiths Medical International , Ltd.
K071221	SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12	Sep 06, 2007	Substantially Equivalent	Automedx, Inc.
K070636	AUTOVENT 4000 WITH CPAP	Jul 13, 2007	Substantially Equivalent	Allied Healthcare Products, Inc.
K070120	AUTOVENT MODEL 4000	May 03, 2007	Substantially Equivalent	Allied Healthcare Products, Inc.
K070210	GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM	Apr 20, 2007	Substantially Equivalent	Ohmeda Medical
K051476	UNI-VENT MODEL 73X	Oct 28, 2005	Substantially Equivalent	Impact Instrumentation, Inc.
K051469	CAREVENT ATV+ AND CAREVENT MRI	Sep 28, 2005	Substantially Equivalent	O-Two Medical Technologies, Inc.
K051889	CAREVENT CA AND DRA	Aug 30, 2005	Substantially Equivalent	O-Two Medical Technologies, Inc.
K051322	PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS	Aug 05, 2005	Substantially Equivalent	Smiths Medical International , Ltd.
K043495	BABYPAC	Apr 22, 2005	Substantially Equivalent	Smiths Medical International Ltd., Luton
K041473	VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM	Jul 15, 2004	Substantially Equivalent	Vortran Medical Technology 1, Inc.
K040090	COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 POWER SUPPLY (MAINS)	May 27, 2004	Substantially Equivalent	Pneupac , Ltd.
K032386	UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)	Mar 26, 2004	Substantially Equivalent	Impact Instrumentation, Inc.
K030803	PARAPAC 200D TRANSPORT, MODEL V200D	Sep 29, 2003	Substantially Equivalent	Pneupac , Ltd.
K021841	COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER	Jul 17, 2003	Substantially Equivalent	Pneupac , Ltd.
K020899	PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200D	Dec 13, 2002	Substantially Equivalent	Pneupac , Ltd.
K021520	EMT-CPAP	Jul 15, 2002	Substantially Equivalent	Emergency Medical Techology
K001430	RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000	Jul 05, 2000	Substantially Equivalent	Vortran Medical Technology 1, Inc.
K991785	MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR	Aug 17, 1999	Substantially Equivalent	Instrumentation Industries, Inc.
K991195	CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV	Apr 22, 1999	Substantially Equivalent	O-Two Systems Intl., Inc.
K983857	AUTOVENT 1500	Nov 04, 1998	Substantially Equivalent	O-Two Systems Intl., Inc.
K983785	AUTOVENT 1000	Oct 29, 1998	Substantially Equivalent	O-Two Systems Intl., Inc.
K983705	EMT RESUSCITATOR	Oct 29, 1998	Substantially Equivalent	O-Two Systems Intl., Inc.
K983643	GENESIS BLS	Oct 29, 1998	Substantially Equivalent	O-Two Systems Intl., Inc.
K982225	SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504	Oct 28, 1998	Substantially Equivalent	Spiracle Technology
K973975	RESPIRTECHPRO	Jun 12, 1998	Substantially Equivalent	Vortran Medical Technology 1, Inc.
K960515	PARAPAC	Oct 10, 1996	Substantially Equivalent	Pneupac , Ltd.
K944349	OXYLATOR EM-100	Apr 17, 1995	Substantially Equivalent	Cpr Medical Devices, Inc.
K951126	DRAGER MEDICAL AIR COMPRESSOR	Mar 24, 1995	Substantially Equivalent	Drager, Inc.
K944397	BNOS MICROVENT, MODEL AC AND MODEL AO	Jan 31, 1995	Unknown	Racal Health & Safety, Inc.
K941871	LSPI AUTOMATIC VENTILATOR, MODEL AV3000-100	Jan 09, 1995	Substantially Equivalent	Life Support Products, Inc.
K941870	LSPI AUTOMATIC VENTILATOR, MODEL AV2000-100	Jan 09, 1995	Substantially Equivalent	Life Support Products, Inc.
K931473	IMPACT MODEL 753	Dec 30, 1994	Substantially Equivalent	Impact Instrumentation, Inc.
K924272	MEDIRESP III	Feb 09, 1994	Substantially Equivalent	Medflow Corp., Inc.
K932200	LSPI AUTOMATIC VENTILATOR	Nov 24, 1993	Substantially Equivalent	Life Support Products, Inc.
K932199	LSPI AUTOMATIC VENTILATOR, MODEL AV3000	Nov 24, 1993	Substantially Equivalent	Life Support Products, Inc.
K932170	FLYNNR GENESIS II A/C, A/O AND IDLH	Oct 25, 1993	Substantially Equivalent	O-Two Systems Intl., Inc.
K920910	OXYGEN POWERED RESUSCITATOR FOR CPR	Jan 12, 1993	Substantially Equivalent	J. H. Emerson Co.
K921926	JET VENTILATOR/JETTING DEVICE	Oct 13, 1992	Substantially Equivalent	Anesthesia Assoc., Inc.
K913039	FLLYNN(R) GENESIS AC	Aug 25, 1992	Substantially Equivalent	O-Two Systems Intl., Inc.
K915564	SPIROS	Jan 30, 1992	Substantially Equivalent	Life Support Products, Inc.
K910699	LIFE-02 (NON-REFILLABLE CYLINDER)	Jun 18, 1991	Substantially Equivalent	Life Corp.
K910435	LIFE OXYGENPAC 6/12 LPM	Jun 17, 1991	Substantially Equivalent	Life Corp.
K910434	LIFE OXYGENPAC FOR TRAINED MEDICAL PERSONNEL	Jun 17, 1991	Substantially Equivalent	Life Corp.
K911261	ERA 2000A	May 31, 1991	Substantially Equivalent	Neotronics, Inc.
K904920	AMBU MATIC AUTOMATIC RESUSCITATOR	May 28, 1991	Substantially Equivalent	Ambu, Inc.
K910201	LIFE O2	Feb 01, 1991	Substantially Equivalent	Life Corp.
K905697	POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE	Dec 27, 1990	Substantially Equivalent	Impact Instrumentation, Inc.
K901846	OHMEDA - LOGIC 07A TRANSPORT VENTILATOR	Aug 08, 1990	Substantially Equivalent	Ohmeda Medical
K895946	BIVONA CARDEN INTERMITTENT JETTING DEVICE	Jan 09, 1990	Substantially Equivalent	Bivona Medical Technologies
K892885	RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR	Oct 06, 1989	Substantially Equivalent	Fisher & Paykel Electronics , Ltd.
K884089	ERA 2000 EMERGENCY RESUSCITATOR	Dec 20, 1988	Substantially Equivalent	Neotronics Medical , Ltd.
K882833	THE BERG RESUSCITATION APPARATUS	Aug 19, 1988	Substantially Equivalent	Hursch Ent., Inc.
K870424	LSP AUTOMATIC VENTILATOR, MODEL 456	Jan 22, 1988	Substantially Equivalent	Life Support Products, Inc.
K874656	AUTOMATIC VENTILATOR AV2000	Jan 19, 1988	Substantially Equivalent	Life Support Products, Inc.
K863410	PATIENT VALVE WITH AIR ENTRAINMENT	Jan 12, 1987	Substantially Equivalent	Pneupac , Ltd.
K862830	MODELS 2R AND 3R PNEUPAC VENTILATOR/RESUSCITATOR	Oct 15, 1986	Substantially Equivalent	Pneupac , Ltd.
K862192	RESUSCITATOR MODELS 10400/10500/10600/10700/10800	Jul 07, 1986	Substantially Equivalent	U.O. Equipment Co.
K861272	IMPACT MODELS 701, 702 AND 703	May 20, 1986	Substantially Equivalent	Impact Instrumentation, Inc.
K860077	SG-066 OXYGEN ENRICHMENT KIT	Feb 18, 1986	Substantially Equivalent	Instrumentation Industries, Inc.
K855092	LIFE CORP. OXYGEN PAC	Jan 21, 1986	Substantially Equivalent	Life Corp.
K853971	REGULATOR-INHALATOR SYSTEM	Dec 09, 1985	Substantially Equivalent	Stephenson Industries, Inc.
K851337	502 RESUSCITATORY INHALATOR VALVE	May 15, 1985	Substantially Equivalent	Life Support Products, Inc.
K841893	MAXAMAN	Aug 30, 1984	Substantially Equivalent	Cryo2 Corp.
K830404	RAD VALVE	Mar 17, 1983	Substantially Equivalent	Khi, Inc.
K800456	EMERGIENCY RESUSCITATOR/INHALOR W/ASPIR.	Mar 18, 1980	Substantially Equivalent	Khi, Inc.
K792453	PNEUPAC OXYGEN THERAPY UNIT	Feb 05, 1980	Substantially Equivalent	Pneupac , Ltd.
K780168	PARAMEDIC O2 KIT	Apr 18, 1978	Substantially Equivalent	Pohlmann Rescue Products, Inc.
K771299	EMERGENCY OXYGEN RESUSCITATOR	Aug 04, 1977	Substantially Equivalent	Fraser Sweatman, Inc.