FDA 510(k) Applications for Medical Device Product Code "BYE"
(Attachment, Breathing, Positive End Expiratory Pressure)

FDA 510(k) Number Applicant Device Name Decision Date
K090317 A PLUS MEDICAL BABI*PLUS BUBBLE PAP VALVE 05/20/2009
K880161 ACKRAD LABORATORIES ACKRAD PEDIATRIC C.P.A.P. SYSTEM 03/04/1988
K110713 AIRWAYS DEVELOPMENT, LLC WATERPAP VALVE 09/12/2011
K851194 AMBU, INC. AMBU CPAP SYSTEM 04/15/1985
K923976 AMBU, INC. AMBU SINGLE PATIENT USE PEEP VALVE 01/05/1993
K895360 BALLARD MEDICAL PRODUCTS C.P.A.P. VALVE AND C.P.P.A. KIT 11/15/1989
K882292 BAXTER CENTRE FOR MEDICAL RESEARCH SULLIVAN NASAL CPAP SYSTEM 06/21/1988
K800755 BOEHRINGER LABORATORIES BOEHRINGER LABS AMBULATORY PEEP VALVE 05/08/1980
K982283 CARADYNE, LTD. WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH 03/09/1999
K981415 CHEEN HOUNG ENT. CO. LTD. 0-20 CM H20 PEEP VALVE 07/14/1998
K875073 CINCINNATI MEDICAL TECHNOLOGIES, INC. "BREATHE-FREE" 02/29/1988
K894690 DEVILBISS HEALTH CARE, INC. CPAP MASK 09/08/1989
K894424 DEVILBISS HEALTH CARE, INC. DEVILBISS MODEL 7351 SERIES 09/18/1989
K893388 DEVILBISS HEALTH CARE, INC. DEVILBISS MODEL 7351D REVITALIZER CPAP SYSTEM 06/23/1989
K092029 DRAEGER MEDICAL AG & CO. KG VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 08/06/2010
K802707 DRAEGER MEDICAL, INC. DRAGER PEEP CONTROL SYSTEM 11/12/1980
K834085 DRAEGER MEDICAL, INC. DRAGER PEEP SYSTEM D 12/16/1983
K831301 DRAEGER MEDICAL, INC. PEEP SYSTEM D 06/08/1983
K830395 DUPACO, INC. PEEPER 03/11/1983
K891540 EDENTEC CORP. EDENTEC MODEL 2860 PRESSURE METER 06/01/1989
K983920 ENGINEERED MEDICAL SYSTEMS EMS PEEP VALVES- ADJUSTABLE 01/22/1999
K932799 ENGINEERED MEDICAL SYSTEMS SINGLE USE MANUAL RESUSCITATOR PEEP VALVE 09/03/1993
K802943 FRASER HARLAKE, INC. POSITIVE END EXPIRATORY PRESSURE VALVE 01/15/1981
K133957 GALEMED CORP. DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE 04/14/2014
K770766 GLOBE SAFETY PRODUCTS, INC. REGULATOR, PRESSURE, EXPIRATORY 05/10/1977
K881833 HEALTHDYNE, INC. NASAL CPAP SYSTEM 06/24/1988
K902062 HUDSON OXYGEN THERAPY SALES CO. PEEP VALVE 09/04/1990
K963347 INSTRUMENTATION INDUSTRIES, INC. REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142 03/19/1997
K923618 INTERNATIONAL RESPIRATORY SYSTEMS, INC. PEEP VALVE 08/03/1992
K953511 KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH KENDALL SHERIDAN CPAP SYSTEM 10/26/1995
K050918 KOO AMERICAS, INC. KOO AMERICAS VALVE PEEP, MODEL KM-809 06/06/2005
K861758 LIFE DESIGN SYSTEMS, INC. CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA 07/14/1986
K854458 LIFE DESIGN SYSTEMS, INC. CUSHION-FLEX TM-CPAP FACE MASK 01/15/1986
K854822 LIFE DESIGN SYSTEMS, INC. LDS PEEP VALVE 02/24/1986
K882219 LIFE SUPPORT PRODUCTS, INC. P.E.E.P. VALVE 08/30/1988
K894779 LIFECARE SERVICES, INC. LIFECARE NASAL MASK KIT CAT. NO. 06-800 01/12/1990
K912240 MALLINCKRODT ANESTHESIA PRODUCTS CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM 08/22/1991
K872202 MED AIR TECHNOLOGY, INC. ADJUSTABLE PEEP VALVE 09/01/1987
K861104 MED AIR TECHNOLOGY, INC. VARIABLE HIGH FLOW DOWNS CPAP GENERATOR 04/28/1986
K961867 MEDICAL MARKETING CONCEPTS PEEP VALVE 08/13/1996
K081266 MERCURY ENTERPRIZES DBA MERCURY MEDICAL MERCURY MEDICAL PEEP VALVE 03/05/2009
K090710 MERCURY MEDICAL MERCURY CPAP 08/20/2009
K874479 MINNEAPOLIS CHILDREN'S SERVICES CORP. MC/CPAP MANIFOLD 12/30/1987
K873170 MOUNTAIN MEDICAL EQUIPMENT, INC. ARIES 09/25/1987
K070416 NEOFORCE GROUP, INC. NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP 05/29/2007
K103833 NEOFORCE GROUP, INC. NEOPIP PATIENT CIRCUIT WITH PEEP 04/20/2011
K962492 NIDEK MEDICAL PRODUCTS, INC. SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM 01/23/1997
K112546 O-TWO MEDICAL TECHNOLOGIES, INC. O_TWO CPAP SYSTEM 12/27/2011
K760230 OHIO MEDICAL PRODUCTS VALVE, PEEP 08/06/1976
K881614 OHMEDA MEDICAL MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER) 04/29/1988
K843835 OHMEDA MEDICAL OHMEDA PEEP VALVE FOR GMS ABSORBER 11/15/1984
K080256 PULMODYNE PULMODYNE CHF FLOW GENERATOR SYSTEM 05/09/2008
K900164 PURITAN BENNETT CORP. AIRWAY DELIVERY & MANAGEMENT (ADAM) NASAL VENTILA. 01/26/1990
K903764 PURITAN BENNETT CORP. COMPANION 318 NASAL CPAP SYSTEM 09/10/1990
K922178 PURITAN BENNETT CORP. COMPANION 318 NASAL CPAP SYSTEM -- MODIFICATION 05/29/1992
K903125 PURITAN BENNETT CORP. PURITAN BENNETT SINGLE PATIENT USE PEEP VALVE 09/04/1990
K871693 PURITAN BENNETT CORP. SLEEP APNEA NASAL CPAP SYSTEM 09/15/1987
K942246 PURITAN-BENNETT PURITAN-BENNETT NASAL CPAP MASK 07/06/1994
K871523 RESPIRONICS, INC. "RESPIRONICS SANDERS BIPAPEASY" 07/16/1987
K883825 RESPIRONICS, INC. MODIFIED SANDERS BI-PAPEASY 12/08/1988
K843889 RESPIRONICS, INC. RESPIRONICS SLEEPEASY NASAL CPAP SYS 12/04/1984
K900113 RESPIRONICS, INC. RESPIRONICS' REMSTAR(TM) SLEEPEASY 03/28/1990
K851396 RESPIRONICS, INC. SANDER'S MASKCPAP BY RESPIRONICS 05/15/1985
K133210 S & T MEDICAL TECHNOLOGIES, INC. B&B BUBBLER 03/28/2014
K122610 SEN MU TECHNOLOGY CO., LTD. PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES 08/05/2013
K001318 SIMS PORTEX, INC. CPAP SYSTEM, MODEL 102001 07/20/2000
K953485 SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. SIMS CPAP SYSTEM 10/26/1995
K860848 SYSTEMS 2000, INC. VITAL FLOW NASAL CPAP SYSTEM 06/12/1986
K950397 TURNKEY INTERGRATION USA, INC. SYSTEM 22 VALVE 04/14/1995
K781332 VICKERS AMERICA MEDICAL CORP. PEEP/CPAP VALVE 10/04/1978
K912578 VITAL SIGNS, INC. 20CM/H20 PEEP VALVE 09/11/1991
K904874 VITAL SIGNS, INC. ADJUSTABLE PEEP VALVE 01/08/1991
K831503 VITAL SIGNS, INC. DOWNS ADJUSTABLE FLOW GENERATOR 09/12/1983
K901728 VITAL SIGNS, INC. ONE-LUNG CPAP DEVICE 08/14/1990
K820404 VITAL SIGNS, INC. PEEP VALVE 03/01/1982
K802070 VITAL SIGNS, INC. VITAL SIGNS PEEP VALVE 09/09/1980
K013884 VYGON S A BOUSSIGNAC C.P.A.P. DEVICE 01/21/2003
K955047 WESTMED INTL. WESTMED CIRCULARIE PEP DEVICES 03/27/1996


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