Attachment, Breathing, Positive End Expiratory Pressure

FDA product code BYE · 78 cleared devices

Class 2 Anesthesiology

Regulation: 21 CFR 868.5965
Review panel: AN
Implant: No
Life sustaining: Yes
Third party review: No
GMP exempt: No
Clearance span: 1976-08-06 – 2016-04-29

BYE 2016-04-29

Besmed PEEP Valve

Applicant Besmed Health Business Corp

K number K160112

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BYE 2013-08-05

PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES

Applicant Sen MU Technology Co., Ltd.

K number K122610

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BYE 2011-12-27

O_TWO CPAP SYSTEM

Applicant O-Two Medical Technologies, Inc.

K number K112546

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BYE 2011-09-12

WATERPAP VALVE

Applicant Airways Development, LLC

K number K110713

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BYE 2011-04-20

NEOPIP PATIENT CIRCUIT WITH PEEP

Applicant Neoforce Group, Inc.

K number K103833

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BYE 2010-08-06

VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310

Applicant Draeger Medical AG & Co. KG

K number K092029

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BYE 2009-08-20

MERCURY CPAP

Applicant Mercury Medical

K number K090710

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BYE 2009-05-20

BABI*PLUS BUBBLE PAP VALVE

Applicant A Plus Medical

K number K090317

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BYE 2009-03-05

MERCURY MEDICAL PEEP VALVE

Applicant Mercury Enterprizes Dba Mercury Medical

K number K081266

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BYE 2008-05-09

PULMODYNE CHF FLOW GENERATOR SYSTEM

Applicant Pulmodyne

K number K080256

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BYE 2007-05-29

NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP

Applicant Neoforce Group, Inc.

K number K070416

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BYE 2005-06-06

KOO AMERICAS VALVE PEEP, MODEL KM-809

Applicant Koo Americas, Inc.

K number K050918

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BYE 2003-01-21

BOUSSIGNAC C.P.A.P. DEVICE

Applicant Vygon SA

K number K013884

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BYE 2000-07-20

CPAP SYSTEM, MODEL 102001

Applicant Sims Portex, Inc.

K number K001318

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BYE 1999-03-09

WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH

Applicant Caradyne, Ltd.

K number K982283

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BYE 1999-01-22

EMS PEEP VALVES- ADJUSTABLE

Applicant Engineered Medical Systems

K number K983920

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BYE 1998-07-14

0-20 CM H20 PEEP VALVE

Applicant Cheen Houng Ent. Co. , Ltd.

K number K981415

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BYE 1997-03-19

REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142

Applicant Instrumentation Industries, Inc.

K number K963347

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BYE 1997-01-23

SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM

Applicant Nidek Medical Products, Inc.

K number K962492

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BYE 1996-08-13

PEEP VALVE

Applicant Medical Marketing Concepts

K number K961867

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BYE 1996-03-27

WESTMED CIRCULARIE PEP DEVICES

Applicant Westmed Intl.

K number K955047

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BYE 1995-10-26

KENDALL SHERIDAN CPAP SYSTEM

Applicant Kendall Healthcare Products Co. Div.Of Tyco Health

K number K953511

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BYE 1995-10-26

SIMS CPAP SYSTEM

Applicant Smiths Industries Medical Systems, Inc.

K number K953485

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BYE 1995-04-14

SYSTEM 22 VALVE

Applicant Turnkey Intergration USA, Inc.

K number K950397

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BYE 1994-07-06

PURITAN-BENNETT NASAL CPAP MASK

Applicant Puritan-Bennett

K number K942246

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BYE 1993-09-03

SINGLE USE MANUAL RESUSCITATOR PEEP VALVE

Applicant Engineered Medical Systems

K number K932799

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BYE 1993-01-05

AMBU SINGLE PATIENT USE PEEP VALVE

Applicant Ambu, Inc.

K number K923976

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BYE 1992-08-03

PEEP VALVE

Applicant International Respiratory Systems, Inc.

K number K923618

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BYE 1992-05-29

COMPANION 318 NASAL CPAP SYSTEM -- MODIFICATION

Applicant Puritan Bennett Corp.

K number K922178

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BYE 1991-09-11

20CM/H20 PEEP VALVE

Applicant Vital Signs, Inc.

K number K912578

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BYE 1991-08-22

CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM

Applicant Mallinckrodt Anesthesia Products

K number K912240

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BYE 1991-01-08

ADJUSTABLE PEEP VALVE

Applicant Vital Signs, Inc.

K number K904874

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BYE 1990-09-10

COMPANION 318 NASAL CPAP SYSTEM

Applicant Puritan Bennett Corp.

K number K903764

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BYE 1990-09-04

PURITAN BENNETT SINGLE PATIENT USE PEEP VALVE

Applicant Puritan Bennett Corp.

K number K903125

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BYE 1990-09-04

PEEP VALVE

Applicant Hudson Oxygen Therapy Sales Co.

K number K902062

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BYE 1990-08-14

ONE-LUNG CPAP DEVICE

Applicant Vital Signs, Inc.

K number K901728

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BYE 1990-03-28

RESPIRONICS' REMSTAR(TM) SLEEPEASY

Applicant Respironics, Inc.

K number K900113

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BYE 1990-01-26

AIRWAY DELIVERY & MANAGEMENT (ADAM) NASAL VENTILA.

Applicant Puritan Bennett Corp.

K number K900164

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BYE 1990-01-12

LIFECARE NASAL MASK KIT CAT. NO. 06-800

Applicant Lifecare Services, Inc.

K number K894779

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BYE 1989-11-15

C.P.A.P. VALVE AND C.P.P.A. KIT

Applicant Ballard Medical Products

K number K895360

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BYE 1989-09-18

DEVILBISS MODEL 7351 SERIES

Applicant Devilbiss Health Care, Inc.

K number K894424

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BYE 1989-09-08

CPAP MASK

Applicant Devilbiss Health Care, Inc.

K number K894690

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BYE 1989-06-23

DEVILBISS MODEL 7351D REVITALIZER CPAP SYSTEM

Applicant Devilbiss Health Care, Inc.

K number K893388

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BYE 1989-06-01

EDENTEC MODEL 2860 PRESSURE METER

Applicant Edentec Corp.

K number K891540

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BYE 1988-12-08

MODIFIED SANDERS BI-PAPEASY

Applicant Respironics, Inc.

K number K883825

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BYE 1988-08-30

P.E.E.P. VALVE

Applicant Life Support Products, Inc.

K number K882219

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BYE 1988-06-24

NASAL CPAP SYSTEM

Applicant Healthdyne, Inc.

K number K881833

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BYE 1988-06-21

SULLIVAN NASAL CPAP SYSTEM

Applicant Baxter Centre For Medical Research

K number K882292

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BYE 1988-04-29

MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER)

Applicant Ohmeda Medical

K number K881614

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BYE 1988-03-04

ACKRAD PEDIATRIC C.P.A.P. SYSTEM

Applicant Ackrad Laboratories

K number K880161

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BYE 1988-02-29

BREATHE-FREE

Applicant Cincinnati Medical Technologies, Inc.

K number K875073

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BYE 1987-12-30

MC/CPAP MANIFOLD

Applicant Minneapolis Children'S Services Corp.

K number K874479

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BYE 1987-09-25

ARIES

Applicant Mountain Medical Equipment, Inc.

K number K873170

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BYE 1987-09-15

SLEEP APNEA NASAL CPAP SYSTEM

Applicant Puritan Bennett Corp.

K number K871693

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BYE 1987-09-01

ADJUSTABLE PEEP VALVE

Applicant Med Air Technology, Inc.

K number K872202

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BYE 1987-07-16

RESPIRONICS SANDERS BIPAPEASY

Applicant Respironics, Inc.

K number K871523

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BYE 1986-07-14

CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA

Applicant Life Design Systems, Inc.

K number K861758

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BYE 1986-06-12

VITAL FLOW NASAL CPAP SYSTEM

Applicant Systems 2000, Inc.

K number K860848

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BYE 1986-04-28

VARIABLE HIGH FLOW DOWNS CPAP GENERATOR

Applicant Med Air Technology, Inc.

K number K861104

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BYE 1986-02-24

LDS PEEP VALVE

Applicant Life Design Systems, Inc.

K number K854822

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BYE 1986-01-15

CUSHION-FLEX TM-CPAP FACE MASK

Applicant Life Design Systems, Inc.

K number K854458

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BYE 1985-05-15

SANDER'S MASKCPAP BY RESPIRONICS

Applicant Respironics, Inc.

K number K851396

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BYE 1985-04-15

AMBU CPAP SYSTEM

Applicant Ambu, Inc.

K number K851194

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BYE 1984-12-04

RESPIRONICS SLEEPEASY NASAL CPAP SYS

Applicant Respironics, Inc.

K number K843889

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BYE 1984-11-15

OHMEDA PEEP VALVE FOR GMS ABSORBER

Applicant Ohmeda Medical

K number K843835

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BYE 1983-12-16

DRAGER PEEP SYSTEM D

Applicant Draeger Medical, Inc.

K number K834085

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BYE 1983-09-12

DOWNS ADJUSTABLE FLOW GENERATOR

Applicant Vital Signs, Inc.

K number K831503

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BYE 1983-06-08

PEEP SYSTEM D

Applicant Draeger Medical, Inc.

K number K831301

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BYE 1983-03-11

PEEPER

Applicant Dupaco, Inc.

K number K830395

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BYE 1982-03-01

PEEP VALVE

Applicant Vital Signs, Inc.

K number K820404

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BYE 1981-01-15

POSITIVE END EXPIRATORY PRESSURE VALVE

Applicant Fraser Harlake, Inc.

K number K802943

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BYE 1980-11-12

DRAGER PEEP CONTROL SYSTEM

Applicant Draeger Medical, Inc.

K number K802707

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BYE 1980-09-09

VITAL SIGNS PEEP VALVE

Applicant Vital Signs, Inc.

K number K802070

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BYE 1980-05-08

BOEHRINGER LABS AMBULATORY PEEP VALVE

Applicant Boehringer Laboratories

K number K800755

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BYE 1978-12-26

VALVE, AMBU PEEP

Applicant Narco Air-Shields

K number K782152

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BYE 1978-10-04

PEEP/CPAP VALVE

Applicant Vickers America Medical Corp.

K number K781332

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BYE 1977-05-10

REGULATOR, PRESSURE, EXPIRATORY

Applicant Globe Safety Products, Inc.

K number K770766

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BYE 1976-08-06

VALVE, PEEP

Applicant Ohio Medical Products

K number K760230

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