Product Code: BYE FDA class 2 21 CFR 868.5965

Attachment, Breathing, Positive End Expiratory Pressure

Anesthesiology

The Attachment, Breathing, Positive End Expiratory Pressure (PEEP) is an accessory device connected to a ventilator or breathing circuit that maintains a positive pressure in the airway at the end of expiration, improving oxygenation by preventing alveolar collapse in patients with respiratory failure. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BYE, regulated under 21 CFR 868.5965 in the Anesthesiology specialty. This device is designated as life-sustaining or life-supporting.

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510(k)s

FEI Numbers

Registration Numbers

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Basic Information

Product Code: BYE
Device Class: FDA class 2
Regulation Number: 868.5965
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 80 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K160112	Besmed PEEP Valve	Apr 29, 2016	Substantially Equivalent	Besmed Health Business Corp
K133957	DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE	Apr 14, 2014	Substantially Equivalent	Galemed Corp.
K133210	B&B BUBBLER	Mar 28, 2014	Substantially Equivalent	S & T Medical Technologies, Inc.
K122610	PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES	Aug 05, 2013	Substantially Equivalent	Sen MU Technology Co., Ltd.
K112546	O_TWO CPAP SYSTEM	Dec 27, 2011	Substantially Equivalent	O-Two Medical Technologies, Inc.
K110713	WATERPAP VALVE	Sep 12, 2011	Substantially Equivalent	Airways Development, LLC
K103833	NEOPIP PATIENT CIRCUIT WITH PEEP	Apr 20, 2011	Substantially Equivalent	Neoforce Group, Inc.
K092029	VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310	Aug 06, 2010	Substantially Equivalent	Draeger Medical AG & Co. KG
K090710	MERCURY CPAP	Aug 20, 2009	Substantially Equivalent	Mercury Medical
K090317	BABI*PLUS BUBBLE PAP VALVE	May 20, 2009	Substantially Equivalent	A Plus Medical
K081266	MERCURY MEDICAL PEEP VALVE	Mar 05, 2009	Substantially Equivalent	Mercury Enterprizes Dba Mercury Medical
K080256	PULMODYNE CHF FLOW GENERATOR SYSTEM	May 09, 2008	Substantially Equivalent	Pulmodyne
K070416	NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP	May 29, 2007	Substantially Equivalent	Neoforce Group, Inc.
K050918	KOO AMERICAS VALVE PEEP, MODEL KM-809	Jun 06, 2005	Substantially Equivalent	Koo Americas, Inc.
K013884	BOUSSIGNAC C.P.A.P. DEVICE	Jan 21, 2003	Substantially Equivalent	Vygon SA
K001318	CPAP SYSTEM, MODEL 102001	Jul 20, 2000	Substantially Equivalent	Sims Portex, Inc.
K982283	WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH	Mar 09, 1999	Substantially Equivalent	Caradyne, Ltd.
K983920	EMS PEEP VALVES- ADJUSTABLE	Jan 22, 1999	Substantially Equivalent	Engineered Medical Systems
K981415	0-20 CM H20 PEEP VALVE	Jul 14, 1998	Substantially Equivalent	Cheen Houng Ent. Co. , Ltd.
K963347	REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142	Mar 19, 1997	Substantially Equivalent	Instrumentation Industries, Inc.
K962492	SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM	Jan 23, 1997	Substantially Equivalent	Nidek Medical Products, Inc.
K961867	PEEP VALVE	Aug 13, 1996	Substantially Equivalent	Medical Marketing Concepts
K955047	WESTMED CIRCULARIE PEP DEVICES	Mar 27, 1996	Substantially Equivalent	Westmed Intl.
K953511	KENDALL SHERIDAN CPAP SYSTEM	Oct 26, 1995	Unknown	Kendall Healthcare Products Co. Div.Of Tyco Health
K953485	SIMS CPAP SYSTEM	Oct 26, 1995	Substantially Equivalent	Smiths Industries Medical Systems, Inc.
K950397	SYSTEM 22 VALVE	Apr 14, 1995	Substantially Equivalent	Turnkey Intergration USA, Inc.
K942246	PURITAN-BENNETT NASAL CPAP MASK	Jul 06, 1994	Substantially Equivalent	Puritan-Bennett
K932799	SINGLE USE MANUAL RESUSCITATOR PEEP VALVE	Sep 03, 1993	Substantially Equivalent	Engineered Medical Systems
K923976	AMBU SINGLE PATIENT USE PEEP VALVE	Jan 05, 1993	Substantially Equivalent	Ambu, Inc.
K923618	PEEP VALVE	Aug 03, 1992	Substantially Equivalent	International Respiratory Systems, Inc.
K922178	COMPANION 318 NASAL CPAP SYSTEM -- MODIFICATION	May 29, 1992	Substantially Equivalent	Puritan Bennett Corp.
K912578	20CM/H20 PEEP VALVE	Sep 11, 1991	Substantially Equivalent	Vital Signs, Inc.
K912240	CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM	Aug 22, 1991	Substantially Equivalent	Mallinckrodt Anesthesia Products
K904874	ADJUSTABLE PEEP VALVE	Jan 08, 1991	Substantially Equivalent	Vital Signs, Inc.
K903764	COMPANION 318 NASAL CPAP SYSTEM	Sep 10, 1990	Substantially Equivalent	Puritan Bennett Corp.
K903125	PURITAN BENNETT SINGLE PATIENT USE PEEP VALVE	Sep 04, 1990	Substantially Equivalent	Puritan Bennett Corp.
K902062	PEEP VALVE	Sep 04, 1990	Substantially Equivalent	Hudson Oxygen Therapy Sales Co.
K901728	ONE-LUNG CPAP DEVICE	Aug 14, 1990	Substantially Equivalent	Vital Signs, Inc.
K900113	RESPIRONICS' REMSTAR(TM) SLEEPEASY	Mar 28, 1990	Substantially Equivalent	Respironics, Inc.
K900164	AIRWAY DELIVERY & MANAGEMENT (ADAM) NASAL VENTILA.	Jan 26, 1990	Substantially Equivalent	Puritan Bennett Corp.
K894779	LIFECARE NASAL MASK KIT CAT. NO. 06-800	Jan 12, 1990	Substantially Equivalent	Lifecare Services, Inc.
K895360	C.P.A.P. VALVE AND C.P.P.A. KIT	Nov 15, 1989	Substantially Equivalent	Ballard Medical Products
K894424	DEVILBISS MODEL 7351 SERIES	Sep 18, 1989	Substantially Equivalent	Devilbiss Health Care, Inc.
K894690	CPAP MASK	Sep 08, 1989	Substantially Equivalent	Devilbiss Health Care, Inc.
K893388	DEVILBISS MODEL 7351D REVITALIZER CPAP SYSTEM	Jun 23, 1989	Substantially Equivalent	Devilbiss Health Care, Inc.
K891540	EDENTEC MODEL 2860 PRESSURE METER	Jun 01, 1989	Substantially Equivalent	Edentec Corp.
K883825	MODIFIED SANDERS BI-PAPEASY	Dec 08, 1988	Substantially Equivalent	Respironics, Inc.
K882219	P.E.E.P. VALVE	Aug 30, 1988	Substantially Equivalent	Life Support Products, Inc.
K881833	NASAL CPAP SYSTEM	Jun 24, 1988	Substantially Equivalent	Healthdyne, Inc.
K882292	SULLIVAN NASAL CPAP SYSTEM	Jun 21, 1988	Substantially Equivalent	Baxter Centre For Medical Research
K881614	MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER)	Apr 29, 1988	Substantially Equivalent	Ohmeda Medical
K880161	ACKRAD PEDIATRIC C.P.A.P. SYSTEM	Mar 04, 1988	Substantially Equivalent	Ackrad Laboratories
K875073	BREATHE-FREE	Feb 29, 1988	Substantially Equivalent	Cincinnati Medical Technologies, Inc.
K874479	MC/CPAP MANIFOLD	Dec 30, 1987	Substantially Equivalent	Minneapolis Children'S Services Corp.
K873170	ARIES	Sep 25, 1987	Substantially Equivalent	Mountain Medical Equipment, Inc.
K871693	SLEEP APNEA NASAL CPAP SYSTEM	Sep 15, 1987	Substantially Equivalent	Puritan Bennett Corp.
K872202	ADJUSTABLE PEEP VALVE	Sep 01, 1987	Substantially Equivalent	Med Air Technology, Inc.
K871523	RESPIRONICS SANDERS BIPAPEASY	Jul 16, 1987	Substantially Equivalent	Respironics, Inc.
K861758	CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA	Jul 14, 1986	Substantially Equivalent	Life Design Systems, Inc.
K860848	VITAL FLOW NASAL CPAP SYSTEM	Jun 12, 1986	Substantially Equivalent	Systems 2000, Inc.
K861104	VARIABLE HIGH FLOW DOWNS CPAP GENERATOR	Apr 28, 1986	Substantially Equivalent	Med Air Technology, Inc.
K854822	LDS PEEP VALVE	Feb 24, 1986	Substantially Equivalent	Life Design Systems, Inc.
K854458	CUSHION-FLEX TM-CPAP FACE MASK	Jan 15, 1986	Substantially Equivalent	Life Design Systems, Inc.
K851396	SANDER'S MASKCPAP BY RESPIRONICS	May 15, 1985	Substantially Equivalent	Respironics, Inc.
K851194	AMBU CPAP SYSTEM	Apr 15, 1985	Substantially Equivalent	Ambu, Inc.
K843889	RESPIRONICS SLEEPEASY NASAL CPAP SYS	Dec 04, 1984	Substantially Equivalent	Respironics, Inc.
K843835	OHMEDA PEEP VALVE FOR GMS ABSORBER	Nov 15, 1984	Substantially Equivalent	Ohmeda Medical
K834085	DRAGER PEEP SYSTEM D	Dec 16, 1983	Substantially Equivalent	Draeger Medical, Inc.
K831503	DOWNS ADJUSTABLE FLOW GENERATOR	Sep 12, 1983	Substantially Equivalent	Vital Signs, Inc.
K831301	PEEP SYSTEM D	Jun 08, 1983	Substantially Equivalent	Draeger Medical, Inc.
K830395	PEEPER	Mar 11, 1983	Substantially Equivalent	Dupaco, Inc.
K820404	PEEP VALVE	Mar 01, 1982	Substantially Equivalent	Vital Signs, Inc.
K802943	POSITIVE END EXPIRATORY PRESSURE VALVE	Jan 15, 1981	Substantially Equivalent	Fraser Harlake, Inc.
K802707	DRAGER PEEP CONTROL SYSTEM	Nov 12, 1980	Substantially Equivalent	Draeger Medical, Inc.
K802070	VITAL SIGNS PEEP VALVE	Sep 09, 1980	Substantially Equivalent	Vital Signs, Inc.
K800755	BOEHRINGER LABS AMBULATORY PEEP VALVE	May 08, 1980	Substantially Equivalent	Boehringer Laboratories
K782152	VALVE, AMBU PEEP	Dec 26, 1978	Unknown	Narco Air-Shields
K781332	PEEP/CPAP VALVE	Oct 04, 1978	Substantially Equivalent	Vickers America Medical Corp.
K770766	REGULATOR, PRESSURE, EXPIRATORY	May 10, 1977	Substantially Equivalent	Globe Safety Products, Inc.
K760230	VALVE, PEEP	Aug 06, 1976	Substantially Equivalent	Ohio Medical Products