Product Code: BTM FDA class 2 21 CFR 868.5915

Ventilator, Emergency, Manual (Resuscitator)

Anesthesiology

The Ventilator, Emergency, Manual (Resuscitator) is a manually operated bag-valve-mask device used to deliver positive pressure ventilation to patients who require respiratory assistance in emergency or resuscitation situations. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BTM, regulated under 21 CFR 868.5915 in the Anesthesiology specialty. This device is designated as life-sustaining or life-supporting and is eligible for third-party 510(k) review.

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510(k)s

209

FEI Numbers

Registration Numbers

Unique Applicants

113

Years Active

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Basic Information

Product Code: BTM
Device Class: FDA class 2
Regulation Number: 868.5915
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 209 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251631	The BAG manual resuscitator and accessories	Nov 24, 2025	Substantially Equivalent	Laerdal Medical AS
K243861	butterflyBVM	Apr 25, 2025	Substantially Equivalent	Compact Medical, Inc.
K221841	EOlife®	Mar 18, 2023	Substantially Equivalent	Archeon
K212905	Sotair Device	Aug 18, 2022	Substantially Equivalent	Safe Bvm Corporation
K210288	Disposable Manual Resuscitator	Aug 26, 2021	Substantially Equivalent	Xiamen Compower Medical Tech. Co., Ltd.
K181583	Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20	Dec 07, 2018	Substantially Equivalent	Flexicare Medical Limited.
K170663	Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer	May 11, 2018	Substantially Equivalent	Foremount Enterprise Co., Ltd.
K152931	Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator	Aug 29, 2016	Substantially Equivalent	Ambu A/S
K132172	NEONATALIE RESUSCITATOR	Jan 15, 2015	Substantially Equivalent	Laerdal Medical A/S
K112852	BABI PLUS NEONATAL RESUSCITATION BAG	Jan 13, 2012	Substantially Equivalent	A Plus Medical
K102824	AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC	Jan 28, 2011	Substantially Equivalent	Ambu A/S
K102649	NEOPOP INFANT RESUSCITATOR WITH FLOW METER	Jan 06, 2011	Substantially Equivalent	Neoforce Group, Inc.
K094003	REVIVATOR	Sep 17, 2010	Substantially Equivalent	Hersill, S.L.
K093081	POCKET BVM	Feb 05, 2010	Substantially Equivalent	Microbvm Systems , Ltd.
K082092	DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE	Oct 15, 2008	Substantially Equivalent	Galemed Corp.
K073410	SAVE RESUSCITATOR	Sep 12, 2008	Substantially Equivalent	Artivent Corporation
K073171	RESUSCITATION TIMER, MODEL L770-CPR	Jan 31, 2008	Substantially Equivalent	Allied Healthcare Products, Inc.
K072021	NEOPIP INFANT RESUSCITATOR	Sep 12, 2007	Substantially Equivalent	Neoforce Group, Inc.
K070247	GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM	Apr 20, 2007	Substantially Equivalent	Ohmeda Medical
K062080	RESUSCITATION TIMER, MODEL L770-CPR	Oct 18, 2006	Substantially Equivalent	Allied Healthcare Products, Inc.
K053466	HSINER RESUSCITATOR	Mar 22, 2006	Substantially Equivalent	Hsiner Co., Ltd.
K053140	AMBU MARK IV RESUSCITATOR	Dec 23, 2005	Substantially Equivalent	Ambu A/S
K053142	AMBU MARK IV BABY RESUSCITATOR	Dec 20, 2005	Substantially Equivalent	Ambu A/S
K051177	PVC AND SILICONE MANUAL RESUSCITATORS	Aug 29, 2005	Substantially Equivalent	David Medical Products Co.,Ltd
K042556	SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022,	Mar 11, 2005	Substantially Equivalent	Enter Medical Corporation
K042682	AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR	Nov 15, 2004	Substantially Equivalent	Ambu, Inc.
K042843	AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS	Nov 12, 2004	Substantially Equivalent	Ambu, Inc.
K032596	STURDY MANUAL RESUSCITATOR	Aug 05, 2004	Substantially Equivalent	Sturdy Industrial Co., Ltd.
K031395	MERLIN RESUSCITATOR	Jul 16, 2004	Substantially Equivalent	Merlin Medical Limited
K031434	BAWMED E-Z BAG RESUSCITATOR	Feb 06, 2004	Substantially Equivalent	Bawmed UK
K030864	VADI MANUAL RESUSCITATOR	Jan 30, 2004	Substantially Equivalent	Vedi Corp.
K021328	SMART BAG MO	Jun 26, 2003	Substantially Equivalent	O-Two Systems International, Inc.
K023793	1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR	Feb 11, 2003	Substantially Equivalent	Portex, Inc.
K023494	NELLCOR INDGO MANUAL RESUSCITATOR	Feb 07, 2003	Substantially Equivalent	Nellcor Puritan Bennett, Inc.
K021446	OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR	Oct 11, 2002	Substantially Equivalent	Oemedic International, Inc.
K021716	SIMPLIFY COMPACT RESUSCITATOR	Oct 08, 2002	Substantially Equivalent	Polymed (Xiamen) Plastic Industrial Co., Ltd.
K021390	PMX COMPACT RESUCITATOR	Oct 04, 2002	Substantially Equivalent	Cheen Houng Ent. Co. , Ltd.
K012271	ACUTEVENTILATOR	Oct 04, 2002	Substantially Equivalent	Impoex International, Ltd.
K014071	PMX DISPOSABLE BAG MASK RESUSCITATOR	Oct 01, 2002	Substantially Equivalent	Allied Healthcare Products, Inc.
K021442	OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & RESERVOIR	Jul 30, 2002	Substantially Equivalent	Oemedic International, Inc.
K014115	1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX	Feb 27, 2002	Substantially Equivalent	Portex, Inc.
K012842	V*CARE MANUAL RESUSCITATOR	Sep 18, 2001	Substantially Equivalent	Ventlab Corp.
K003927	Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02	Jun 26, 2001	Substantially Equivalent	Cheen Houng Ent. Co. , Ltd.
K002846	HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR	Jun 06, 2001	Substantially Equivalent	Headstar Medical Products Co., Ltd.
K993278	AMBU NEONATE SILICONE RESUSCITATOR	May 17, 2000	Substantially Equivalent	Ambu, Inc.
K993194	RUSCH MANUAL RESUSCITATOR BAG	Mar 24, 2000	Substantially Equivalent	Rusch, Inc.
K991861	1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE	Jan 18, 2000	Substantially Equivalent	Sims Portex, Inc.
K992057	IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006	Sep 13, 1999	Substantially Equivalent	Sims Portex, Inc.
K991955	MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION	Jul 06, 1999	Substantially Equivalent	Engineered Medical Systems
K991953	MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION	Jul 01, 1999	Substantially Equivalent	Engineered Medical Systems
K982215	MANUAL RESUSCITATOR WITH ACE	Sep 18, 1998	Substantially Equivalent	Medical Marketing Concepts
K980066	CPR FILTERSHIELD	Jul 16, 1998	Substantially Equivalent	Plasco, Inc.
K981308	INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL PULMONARY RESUSCITATOR WITH RUBBER COMPRESSION BAG	Jul 06, 1998	Substantially Equivalent	International Respiratory Systems, Inc.
K981307	INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR	Jul 06, 1998	Substantially Equivalent	International Respiratory Systems, Inc.
K974141	PLUS REUSABLE RESUSCITATOR	May 21, 1998	Substantially Equivalent	Schiff & Co.
K973419	DMR PLUS DISPOSABLE MANUAL RESUSCITATOR	Mar 25, 1998	Substantially Equivalent	Nellcor Puritan Bennett, Inc.
K973106	GOLEMB DISPOSABLE BAG MASK RESUSCITATOR	Jan 29, 1998	Substantially Equivalent	Allied Healthcare Products, Inc.
K971243	OHMEDA INFANT RESUSCITATION SYSTEM	Dec 02, 1997	Substantially Equivalent	Ohmeda Medical
K970756	MERCURY MEDICAL REUSABLE CPR BAG	Oct 31, 1997	Substantially Equivalent	Mercury Medical
K972283	SIMS 1ST RESPONSE MANUAL RESUSCITATOR, ADULT	Sep 17, 1997	Substantially Equivalent	Sims
K972139	ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOPE ADAPTER,IN-LINE SPECIMEN TRAP	Sep 03, 1997	Substantially Equivalent	Davis & Geck, Inc.
K963848	MANUAL RESUSCITATOR	Jul 07, 1997	Substantially Equivalent	Owens-Brigam Medical Co.
K970991	DATEX ENGSTOM MANUAL RESUSCITATOR	Jun 16, 1997	Unknown	Promedic, Inc.
K970959	INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT)	Jun 13, 1997	Substantially Equivalent	Instrumentation Industries, Inc.
K964584	AMBU SPUR NEONATE	May 15, 1997	Substantially Equivalent	Ambu, Inc.
K964719	HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR	Feb 21, 1997	Substantially Equivalent	Hudson Respiratory Care, Inc.
K955507	GRAYCO POCKET PUMP	Aug 15, 1996	Substantially Equivalent	Grayco, Inc.
K961330	BAGRIGHT INFANT RESUSCITATOR	Jul 02, 1996	Substantially Equivalent	Medical Marketing Concepts
K961329	BAGRIGHT CHILD RESUSCITATOR	Jul 02, 1996	Substantially Equivalent	Medical Marketing Concepts
K961882	RESPOSABLE INFANT RESUSCITATOR	Jun 28, 1996	Substantially Equivalent	Medical Marketing Concepts
K961868	RESPOSABLE CHILD RESUSCITATOR	Jun 28, 1996	Substantially Equivalent	Medical Marketing Concepts
K961369	BAGRIGHT RESPOSABLE RESUSCITATOR	Jun 28, 1996	Substantially Equivalent	Medical Marketing Concepts
K961332	BAGRIGHT RESPOSABLE INFANT RESUSCITATOR	Jun 28, 1996	Substantially Equivalent	Medical Marketing Concepts
K961331	BAGRIGHT RESPOSABLE CHILD RESUSCITATOR	Jun 28, 1996	Substantially Equivalent	Medical Marketing Concepts
K960468	DMR/CO2 COMBO KTI	Apr 26, 1996	Unknown	Nellcor Puritan Bennett, Inc.
K953546	MANUAL PULMONARY RESUSICITATOR	Feb 29, 1996	Substantially Equivalent	Medical Marketing Concepts
K954866	MERCURY CPR (COMPLETE PERSONAL RESUSCIATOR) BAG WITH EXPANDABLE RESERVOIR	Jan 30, 1996	Substantially Equivalent	Mercury Medical
K954296	BAGRIGHT RESUSCITATOR	Dec 20, 1995	Substantially Equivalent	Medical Marketing Concepts
K954150	VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)	Dec 20, 1995	Substantially Equivalent	Green Field Medical Sourcing, Inc.
K953617	RESPOSABLE RESUSCITATOR	Nov 22, 1995	Substantially Equivalent	Medical Marketing Concepts
K953824	LIFEMASK FACE SHIELD	Sep 19, 1995	Substantially Equivalent	Carefree Trading, Inc.
K952512	CAPNO-FLO REGULATOR, CAPNO-FLO	Aug 28, 1995	Substantially Equivalent	Kirk Specialty Systems
K952169	SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC	Jun 08, 1995	Substantially Equivalent	Intertech Resources, Inc.
K934699	RESPIRONICS BAGEASY ENCOR ADULT SEMI-REUSABLE	Jan 05, 1995	Substantially Equivalent	Respironics, Inc.
K944301	HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR CATALOG NUMBERS: 5360 THROUGH 5380	Dec 21, 1994	Substantially Equivalent	Hudson Respiratory Care, Inc.
K944347	PURITAN-BENNETT DISPOSABLE MANUAL RESUSCITATOR (DMR)	Dec 12, 1994	Substantially Equivalent	Puritan Bennett Corp.
K921982	MATRX HOPE(R) 5 RESUSCITATOR	Oct 28, 1994	Substantially Equivalent	Matrix Medica, Inc.
K941037	BNOS MICRO VENT, MODEL AC AND MODEL AO	Aug 18, 1994	Substantially Equivalent	Reeves Manufactoring
K943617	DISPOSABLE MANUAL RESUSCITATOR	Aug 11, 1994	Substantially Equivalent	Puritan-Bennett
K940581	BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS	May 06, 1994	Substantially Equivalent	Respironics, Inc.
K934310	BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR	Dec 14, 1993	Substantially Equivalent	Respironics, Inc.
K922819	INFANT DISPOSABLE BAG MASK RESUSCITATOR	Nov 24, 1993	Substantially Equivalent	Life Support Products, Inc.
K922691	LSP (MODEL 554) BAG MASK RESUSCITATOR	Nov 24, 1993	Substantially Equivalent	Life Support Products, Inc.
K933626	CAPNO-FLO	Oct 06, 1993	Substantially Equivalent	Kirk Specialty Systems
K932797	PRESSURE LIMITING ELBOW	Sep 03, 1993	Substantially Equivalent	Engineered Medical Systems
K924671	BAXTER ADULT/PEDI INFANT SINGLE/USE MAN RESUSCIT	Apr 21, 1993	Substantially Equivalent	Engineered Medical Systems
K924610	BAXTER ADULT/PEDI/INFANT SINGLE USE MAN RESUSCIT	Apr 06, 1993	Substantially Equivalent	Engineered Medical Systems
K930429	AID, CARDIOPULMONARY RESUSCITATION	Mar 11, 1993	Substantially Equivalent	Valley Forge Scientific Corp.
K923762	SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE	Feb 05, 1993	Substantially Equivalent	Ambu, Inc.
K913474	RESPIRE DISPOSABLE PULMONARY RESUSCITATOR	Feb 03, 1993	Substantially Equivalent	Med-Tek Innovations, Inc.
K922810	ODYSSEY	Jan 22, 1993	Substantially Equivalent	O-Two Systems Intl., Inc.
K913714	MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM)	Dec 01, 1992	Substantially Equivalent	Life Design Systems, Inc.
K921553	LSPI INFANT BAG MASK	Oct 19, 1992	Substantially Equivalent	Life Support Products, Inc.
K921002	RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIED	Oct 06, 1992	Substantially Equivalent	Rondex Products, Inc.
K924217	LSPI DISPOSABLE BAG MASK RESUSCITATOR/MODIFIED	Sep 17, 1992	Substantially Equivalent	Life Support Products, Inc.
K924216	AMBU SILICONE RESUSCITATOR INFAN/CHILD W/OPEN RESO	Sep 16, 1992	Substantially Equivalent	Ambu, Inc.
K924215	AMBU SILICONE RESUSCITATOR, ADULT W/OPEN RESERVOIR	Sep 16, 1992	Substantially Equivalent	Ambu, Inc.
K922712	SPUR INFANT/CHILD WITH OPEN RESERVOIR SYSTEM	Jun 19, 1992	Substantially Equivalent	Ambu, Inc.
K922707	SPUR ADULT WITH OPEN RESERVOIR SYSTEM	Jun 19, 1992	Substantially Equivalent	Ambu, Inc.
K922004	MODIFICATION PURITAN-BENNETT INFANT PM2	May 28, 1992	Substantially Equivalent	Puritan Bennett Corp.
K915810	MER BAG	Mar 09, 1992	Substantially Equivalent	Merced Medical, Inc.
K920570	PURITAN-BENNET INFANT MANUAL RESUSCITATOR MODIFIED	Feb 27, 1992	Substantially Equivalent	Puritan Bennett Corp.
K913900	V*CARE MANUAL RESUSCITATOR, CAT#VR-1000	Jan 07, 1992	Substantially Equivalent	Ventlab Corp.
K912620	OPOMAT MANUAL RESUSCITATOR VENTILATOR	Dec 04, 1991	Substantially Equivalent	Euro-Am Pharma, Inc.
K912203	EMS SINGLE USE MANUAL RESUSCITATORS	Nov 13, 1991	Substantially Equivalent	Engineered Medical Systems
K914196	RONDEX MASKS MODELS 9015/9011/901102 MODIFIED	Nov 08, 1991	Substantially Equivalent	Rondex Products, Inc.
K914187	AMBU SILICONE RESUSCITATOR INFANT/CHILD	Oct 07, 1991	Substantially Equivalent	Ambu, Inc.
K913370	MODIFICATION MANUAL RESUSCITATOR (PMR 2)	Aug 26, 1991	Substantially Equivalent	Puritan Bennett Corp.
K911971	MODIFIED SINGLE PATIENT USE DISP. MANUAL RESUSCIT.	Aug 09, 1991	Substantially Equivalent	Puritan Bennett Corp.
K912625	MOUTH TO MASK RESUSCITATOR	Aug 02, 1991	Substantially Equivalent	Vital Signs, Inc.
K904899	VITAL SIGNS CODE BLUE ADULT MANUAL RESUSCITATOR	Jul 24, 1991	Substantially Equivalent	Vital Signs, Inc.
K911298	PRESSURE LIMITING ELBOW WITH MANOMETER PORT	Jun 25, 1991	Substantially Equivalent	Intertech Resources, Inc.
K910856	MANUAL RESUSCITATOR	Jun 18, 1991	Substantially Equivalent	Vital Signs, Inc.
K910040	AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT	May 28, 1991	Substantially Equivalent	Ambu, Inc.
K911622	CPR BAG	May 20, 1991	Substantially Equivalent	Merced Medical, Inc.
K905304	DRESSER ARGUS P/N 1818	Apr 17, 1991	Substantially Equivalent	Dresser Argus, Inc.
K905002	SINGLE USE MANUAL RESUSCITATORS	Mar 29, 1991	Substantially Equivalent	Custom Medical, Inc.
K904346	BAUMAN CPR/RESUSCITATOR	Oct 02, 1990	Substantially Equivalent	General Medical Products, Inc.
K902733	1ST RESPONSE (TM) INFANT MANUAL RESUSCITATOR	Aug 22, 1990	Substantially Equivalent	Intertech Resources, Inc.
K903631	INFANT MANUAL RESUSCITATOR (PMR 2)	Aug 17, 1990	Substantially Equivalent	Puritan Bennett Corp.
K903570	SINGLE PATIENT USE INFANT DISPOSABLE MANUAL RESUSC	Aug 17, 1990	Substantially Equivalent	Puritan Bennett Corp.
K903443	MODIFIED SINGLE PATIENT USE DISP MAN RESUSCITATOR	Aug 17, 1990	Substantially Equivalent	Puritan Bennett Corp.
K903438	MOD PURITAN BENNETT SING PATIENT DISPOS MAN RESUS	Aug 17, 1990	Substantially Equivalent	Puritan Bennett Corp.
K902261	AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR) INFANT	Jul 16, 1990	Substantially Equivalent	Ambu, Inc.
K900577	1ST RESPONSE REUSABLE MANUAL RESUSCITATOR (ADULT)	Jul 16, 1990	Substantially Equivalent	Intertech Resources, Inc.
K900260	AMBU LIFE KEY AND AMBU RES-CUE KEY	Jun 08, 1990	Substantially Equivalent	Ambu, Inc.
K901218	LIFE AID RESUSCITATOR	May 18, 1990	Substantially Equivalent	Clarendon Supplies , Ltd.
K900349	PURITAN BENNETT SINGLE PATIENT USE PEEP ADAPTER	May 01, 1990	Substantially Equivalent	Puritan Bennett Corp.
K895820	RESUSO MASK	Apr 04, 1990	Substantially Equivalent	Rml Ent., Inc.
K895589	MANUAL RESUSCITATOR	Mar 30, 1990	Substantially Equivalent	Hudson Oxygen Therapy Sales Co.
K896886	ARTEC RESPOND PULMONARY RESUSCITATOR	Feb 06, 1990	Substantially Equivalent	Artec Environmental Monitoring Division
K895351	RESPIRONICS INFANT BAGEASY	Oct 27, 1989	Substantially Equivalent	Respironics, Inc.
K895169	MANUAL DISPOSABLE PULMONARY RESUSCITATOR	Oct 13, 1989	Substantially Equivalent	F.L.W. Plastics, Inc.
K894365	SINGLE PATIENT USE DISPOSABLE MANUAL RESUSCITATOR	Oct 06, 1989	Substantially Equivalent	Puritan Bennett Corp.
K885243	NEOVO2R VENTILATORY	Jul 24, 1989	Substantially Equivalent	Neomed
K892221	PULMONARY RESUSCITATOR, MODIFICATION	May 18, 1989	Substantially Equivalent	Life Design Systems, Inc.
K881881	OXYGENATION CATHETER	Feb 17, 1989	Substantially Equivalent	Ventech Healthcare Corp., Inc.
K881483	AIRWAY-CIRCULATION EVALUATOR	Dec 16, 1988	Substantially Equivalent	Resuscitation Ace, Inc.
K884526	ADULT RESUSCITATOR WITH MASK AND FILTER	Nov 16, 1988	Substantially Equivalent	Intertech/Ohio
K884068	PULMANEX TM (NEO-NATAL SIZE)	Nov 16, 1988	Substantially Equivalent	Life Design Systems, Inc.
K883434	AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR)	Sep 14, 1988	Substantially Equivalent	Ambu, Inc.
K882285	NONREBREATHING CIRCUIT	Aug 16, 1988	Substantially Equivalent	Dryden Corp.
K881207	RES-Q 1, 2, 3, 4 AND 5	Aug 15, 1988	Substantially Equivalent	Nova-Ventrx
K881686	CPR BAG	Jun 23, 1988	Substantially Equivalent	Devolve Corp.
K882278	RESUSCITATION BAG CONTROLLER (RBC)	Jun 16, 1988	Substantially Equivalent	Physician Engineered Products, Inc.
K881087	LIFEGUARD SINGLE USE MANUAL RESUSCITATORS	Apr 14, 1988	Substantially Equivalent	Lifeguard Medical Products, Inc.
K881086	LIFEGUARD MOUTH TO MASK RESUSCITATOR	Apr 14, 1988	Substantially Equivalent	Lifeguard Medical Products, Inc.
K880450	RESUSCI PATIENT FACE SHIELD	Mar 04, 1988	Substantially Equivalent	Laerdal Medical Corp.
K880394	FIRST RESPONSE PEDIATRIC EMERGENCY RESUSCITATOR	Feb 29, 1988	Substantially Equivalent	Intertech/Ohio
K874567	RESUSCITATOR	Feb 29, 1988	Substantially Equivalent	American Medical Technology, Inc.
K874418	LSP DISPOSABLE BAG RESUSCITATOR, MODEL 470	Jan 22, 1988	Substantially Equivalent	Life Support Products, Inc.
K875077	HERCO SILICONE RESUSCITATOR OR SUN-MED RESUSCITA.	Jan 19, 1988	Substantially Equivalent	Herco Products, Inc.
K874321	SOLCO SILICONE RESUSCITATOR	Jan 19, 1988	Substantially Equivalent	Kahn-Tact U.S.A., Inc.
K873286	DISPOSABLE, MANUAL PULMONARY RESUSCITATOR	Oct 26, 1987	Substantially Equivalent	Hospitak, Inc.
K873043	MOUTH TO FACE RESUSCITATOR	Sep 28, 1987	Substantially Equivalent	Artec Environmental Monitoring Division
K871147	MODIFIED CPREVIVER	Apr 20, 1987	Substantially Equivalent	Augerscope, Inc.
K864308	BAUMAN CPR/RESPIRATOR	Mar 09, 1987	Substantially Equivalent	General Medical Products, Inc.
K864125	CPREVIVER	Feb 26, 1987	Substantially Equivalent	Augerscope, Inc.
K863026	PULMANEX TM (MODIFICATION)	Aug 26, 1986	Substantially Equivalent	Life Design Systems, Inc.
K860693	PULMANEX (TM)	Mar 27, 1986	Substantially Equivalent	Life Design Systems, Inc.
K860180	MODEL 446 & 447 MOUTH TO MASK RESUSCITATOR	Mar 06, 1986	Substantially Equivalent	Life Support Products, Inc.
K854037	PULMANEX	Nov 01, 1985	Substantially Equivalent	Life Design Systems, Inc.
K851171	COMBIBAG MANUAL RESUSCITATOR	Sep 06, 1985	Substantially Equivalent	Frontline Medical Corp.
K852096	RESUS-AID DISPOSABLE RESUSCITATION SHIELD	Jul 08, 1985	Substantially Equivalent	Emergency Situation Products
K844729	RESUSCITATOR, PULMONARY, MANUAL	Mar 25, 1985	Substantially Equivalent	Life Design Systems, Inc.
K850436	STAT BLUE DISPOS. MANUAL RESUSCITATOR	Feb 26, 1985	Substantially Equivalent	Vital Signs, Inc.
K844420	MED-LIFE EMERGENCY OXYGEN REGREATHER/RESUSCITATOR	Dec 17, 1984	Substantially Equivalent	Med-Life, Inc.
K843223	FLOW CONTROLLER	Sep 27, 1984	Substantially Equivalent	Precision Medical, Inc.
K842693	RESPIRONICS VENTEASY	Aug 10, 1984	Substantially Equivalent	Respironics, Inc.
K842696	LIFE-MASK INFANT RESUSCITATOR	Jul 27, 1984	Substantially Equivalent	Electronic Monitors, Inc.
K842487	SAMSON'S NEWBORN LUNG INFLATOR 340-1000	Jul 06, 1984	Substantially Equivalent	J. H. Emerson Co.
K841496	FRASER HARLAKE HOPE III RESUSCITATOR	Apr 24, 1984	Substantially Equivalent	Fraser Harlake, Inc.
K840935	MANUAL RESUSCITATION SYSTEM	Apr 05, 1984	Substantially Equivalent	Inspiron Corp.
K840349	MARK III RESUSCITATOR	Feb 10, 1984	Substantially Equivalent	Ambu, Inc.
K834250	RESCUE MASK	Jan 18, 1984	Substantially Equivalent	Rondex Products, Inc.
K834400	FLYNN III-CHILD BAG-MASK UNIT ETC	Jan 13, 1984	Substantially Equivalent	O-Two Systems Intl., Inc.
K833244	REVIVE	Nov 29, 1983	Substantially Equivalent	Aladdin Industries, Inc.
K832495	FLYNN SERIES III BAG/MASK UNIT-	Sep 29, 1983	Substantially Equivalent	O-Two Systems Intl., Inc.
K831885	CODE BLUE MANUAL RESUSCITATOR	Sep 08, 1983	Substantially Equivalent	Vital Signs, Inc.
K831486	SC-603 TWIN VALVE	Aug 12, 1983	Substantially Equivalent	Instrumentation Industries, Inc.
K831198	CPR HEARTSAVER AND BREATHOLATOR	Jun 24, 1983	Substantially Equivalent	Cervco Corp.
K823710	DISPOSABLE AIRWAY ADEJUNCT	Jan 21, 1983	Substantially Equivalent	Groves Medical Supply, Inc.
K823408	BE#1000-INSTANT ON/OFF O2 VALVE	Dec 07, 1982	Substantially Equivalent	Instrumentation Industries, Inc.
K822213	SIEMENS-ELEMA AB AGA REVIVATOR	Oct 28, 1982	Substantially Equivalent	Siemens Elema AB
K822356	MODULAIDE EMERG. CARDIAC LIFE SUPP. KT	Aug 20, 1982	Substantially Equivalent	Laerdal Medical Corp.
K820059	RESUSCITATION MASK	Mar 26, 1982	Substantially Equivalent	Cederroth, Inc. USA
K812273	RESUSCITATION CIRCUIT	Aug 25, 1981	Substantially Equivalent	Vital Signs, Inc.
K812022	ZEE MANUAL RESUSCITATOR	Jul 31, 1981	Substantially Equivalent	Zee Medical Products Co., Inc.
K803066	DISPOSABLE BAG MASK ADEJUNCT	Feb 12, 1981	Substantially Equivalent	T. S. Enterprises, Inc.
K802813	PMR-2 PURITAN MANUAL RESUSCITATOR	Dec 17, 1980	Substantially Equivalent	Puritan Bennett Corp.
K802231	AIR VIVA II	Oct 10, 1980	Substantially Equivalent	General Medical Co.
K802081	AULD BAGGER KIT	Sep 26, 1980	Substantially Equivalent	Modern Medical Systems Co.
K792118	AIR-SHIELDS RESUSCITATORS	Nov 13, 1979	Substantially Equivalent	Narco Air-Shields
K791468	RESUSCI-BAG-VALVE	Aug 22, 1979	Substantially Equivalent	Concept, Inc.
K780216	LIFESAVER, MANUAL #5160	Mar 14, 1978	Substantially Equivalent	Hudson Oxygen Therapy Sales Co.
K771350	AMBU RESUSCITATOR	Aug 19, 1977	Substantially Equivalent	Air-Shields, Inc.
K771175	RESUSCITATOR, MS30	Aug 02, 1977	Substantially Equivalent	Mckesson Corp.
K761065	NEONATAL RESUSCITATOR, SAMSON	Jan 26, 1977	Substantially Equivalent	Dem Medical, Inc.
K761025	BAG RESUSCITATOR	Nov 24, 1976	Substantially Equivalent	Robert Shaw Controls Co.