Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

BYE — Predicate Candidate Screening

80 FDA 510(k) clearances under this product code; the 50 most recent screened below.

79 daysmedian FDA review time

181 days90th percentile

80clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K160112	Besmed PEEP Valve	Besmed Health Business Corp	2016-04-29	101	0
K133957	DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE	Galemed Corp.	2014-04-14	112	0
K133210	B&B BUBBLER	S & T Medical Technologies, Inc.	2014-03-28	162	0
K122610	PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES	Sen MU Technology Co., Ltd.	2013-08-05	343	0
K112546	O_TWO CPAP SYSTEM	O-Two Medical Technologies, Inc.	2011-12-27	117	0
K110713	WATERPAP VALVE	Airways Development, LLC	2011-09-12	181	1
K103833	NEOPIP PATIENT CIRCUIT WITH PEEP	Neoforce Group, Inc.	2011-04-20	111	0
K092029	VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE	Draeger Medical AG & Co. KG	2010-08-06	396	0
K090710	MERCURY CPAP	Mercury Medical	2009-08-20	155	0
K090317	BABI*PLUS BUBBLE PAP VALVE	A Plus Medical	2009-05-20	100	0
K081266	MERCURY MEDICAL PEEP VALVE	Mercury Enterprizes Dba Mercury Medical	2009-03-05	304	0
K080256	PULMODYNE CHF FLOW GENERATOR SYSTEM	Pulmodyne	2008-05-09	99	0
K070416	NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP	Neoforce Group, Inc.	2007-05-29	106	0
K050918	KOO AMERICAS VALVE PEEP, MODEL KM-809	Koo Americas, Inc.	2005-06-06	55	0
K013884	BOUSSIGNAC C.P.A.P. DEVICE	Vygon SA	2003-01-21	424	0
K001318	CPAP SYSTEM, MODEL 102001	Sims Portex, Inc.	2000-07-20	85	0
K982283	WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500	Caradyne, Ltd.	1999-03-09	252	0
K983920	EMS PEEP VALVES- ADJUSTABLE	Engineered Medical Systems	1999-01-22	79	0
K981415	0-20 CM H20 PEEP VALVE	Cheen Houng Ent. Co. , Ltd.	1998-07-14	85	0
K963347	REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142	Instrumentation Industries, Inc.	1997-03-19	205	0
K962492	SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM	Nidek Medical Products, Inc.	1997-01-23	211	0
K961867	PEEP VALVE	Medical Marketing Concepts	1996-08-13	90	0
K955047	WESTMED CIRCULARIE PEP DEVICES	Westmed Intl.	1996-03-27	145	0
K953485	SIMS CPAP SYSTEM	Smiths Industries Medical Systems, Inc.	1995-10-26	94	0
K953511	KENDALL SHERIDAN CPAP SYSTEM	Kendall Healthcare Products Co. Div.Of Tyco Health	1995-10-26	92	0
K950397	SYSTEM 22 VALVE	Turnkey Intergration USA, Inc.	1995-04-14	72	0
K942246	PURITAN-BENNETT NASAL CPAP MASK	Puritan-Bennett	1994-07-06	58	0
K932799	SINGLE USE MANUAL RESUSCITATOR PEEP VALVE	Engineered Medical Systems	1993-09-03	86	0
K923976	AMBU SINGLE PATIENT USE PEEP VALVE	Ambu, Inc.	1993-01-05	151	0
K923618	PEEP VALVE	International Respiratory Systems, Inc.	1992-08-03	13	0
K922178	COMPANION 318 NASAL CPAP SYSTEM -- MODIFICATION	Puritan Bennett Corp.	1992-05-29	21	0
K912578	20CM/H20 PEEP VALVE	Vital Signs, Inc.	1991-09-11	91	0
K912240	CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM	Mallinckrodt Anesthesia Products	1991-08-22	93	0
K904874	ADJUSTABLE PEEP VALVE	Vital Signs, Inc.	1991-01-08	70	0
K903764	COMPANION 318 NASAL CPAP SYSTEM	Puritan Bennett Corp.	1990-09-10	21	0
K902062	PEEP VALVE	Hudson Oxygen Therapy Sales Co.	1990-09-04	119	0
K903125	PURITAN BENNETT SINGLE PATIENT USE PEEP VALVE	Puritan Bennett Corp.	1990-09-04	50	0
K901728	ONE-LUNG CPAP DEVICE	Vital Signs, Inc.	1990-08-14	120	0
K900113	RESPIRONICS' REMSTAR(TM) SLEEPEASY	Respironics, Inc.	1990-03-28	78	0
K900164	AIRWAY DELIVERY & MANAGEMENT (ADAM) NASAL VENTILA.	Puritan Bennett Corp.	1990-01-26	14	0
K894779	LIFECARE NASAL MASK KIT CAT. NO. 06-800	Lifecare Services, Inc.	1990-01-12	169	0
K895360	C.P.A.P. VALVE AND C.P.P.A. KIT	Ballard Medical Products	1989-11-15	79	0
K894424	DEVILBISS MODEL 7351 SERIES	Devilbiss Health Care, Inc.	1989-09-18	63	0
K894690	CPAP MASK	Devilbiss Health Care, Inc.	1989-09-08	46	0
K893388	DEVILBISS MODEL 7351D REVITALIZER CPAP SYSTEM	Devilbiss Health Care, Inc.	1989-06-23	53	0
K891540	EDENTEC MODEL 2860 PRESSURE METER	Edentec Corp.	1989-06-01	76	0
K883825	MODIFIED SANDERS BI-PAPEASY	Respironics, Inc.	1988-12-08	90	0
K882219	P.E.E.P. VALVE	Life Support Products, Inc.	1988-08-30	96	0
K881833	NASAL CPAP SYSTEM	Healthdyne, Inc.	1988-06-24	56	0
K882292	SULLIVAN NASAL CPAP SYSTEM	Baxter Centre For Medical Research	1988-06-21	20	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda