← [Anesthesiology](/submissions/AN) · Product Code BYE # BYE · Attachment, Breathing, Positive End Expiratory Pressure _Anesthesiology · 21 CFR 868.5965 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE ## Overview - **Product Code:** BYE - **Device Name:** Attachment, Breathing, Positive End Expiratory Pressure - **Regulation:** 21 CFR 868.5965 - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) - **Life-sustaining:** yes ## Identification A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation. ## Classification Rationale Class II (performance standards). ## Cleared Devices (80) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K160112](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K160112.md) | Besmed PEEP Valve | Besmed Health Business Corp | Apr 29, 2016 | SESE | | [K133957](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K133957.md) | DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE | Galemed Corp. | Apr 14, 2014 | SESE | | [K133210](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K133210.md) | B&B BUBBLER | S & T Medical Technologies, Inc. | Mar 28, 2014 | SESE | | [K122610](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K122610.md) | PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES | Sen MU Technology Co., Ltd. | Aug 5, 2013 | SESE | | [K112546](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K112546.md) | O_TWO CPAP SYSTEM | O-Two Medical Technologies, Inc. | Dec 27, 2011 | SESE | | [K110713](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K110713.md) | WATERPAP VALVE | Airways Development, LLC | Sep 12, 2011 | SESE | | [K103833](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K103833.md) | NEOPIP PATIENT CIRCUIT WITH PEEP | Neoforce Group, Inc. | Apr 20, 2011 | SESE | | [K092029](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K092029.md) | VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 | Draeger Medical AG & Co. KG | Aug 6, 2010 | SESE | | [K090710](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K090710.md) | MERCURY CPAP | Mercury Medical | Aug 20, 2009 | SESE | | [K090317](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K090317.md) | BABI*PLUS BUBBLE PAP VALVE | A Plus Medical | May 20, 2009 | SESE | | [K081266](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K081266.md) | MERCURY MEDICAL PEEP VALVE | Mercury Enterprizes Dba Mercury Medical | Mar 5, 2009 | SESE | | [K080256](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K080256.md) | PULMODYNE CHF FLOW GENERATOR SYSTEM | Pulmodyne | May 9, 2008 | SESE | | [K070416](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K070416.md) | NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP | Neoforce Group, Inc. | May 29, 2007 | SESE | | [K050918](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K050918.md) | KOO AMERICAS VALVE PEEP, MODEL KM-809 | Koo Americas, Inc. | Jun 6, 2005 | SESE | | [K013884](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K013884.md) | BOUSSIGNAC C.P.A.P. DEVICE | Vygon SA | Jan 21, 2003 | SESE | | [K001318](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K001318.md) | CPAP SYSTEM, MODEL 102001 | Sims Portex, Inc. | Jul 20, 2000 | SESE | | [K982283](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K982283.md) | WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH | Caradyne, Ltd. | Mar 9, 1999 | SESE | | [K983920](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K983920.md) | EMS PEEP VALVES- ADJUSTABLE | Engineered Medical Systems | Jan 22, 1999 | SESE | | [K981415](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K981415.md) | 0-20 CM H20 PEEP VALVE | Cheen Houng Ent. Co. , Ltd. | Jul 14, 1998 | SESE | | [K963347](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K963347.md) | REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142 | Instrumentation Industries, Inc. | Mar 19, 1997 | SESE | | [K962492](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K962492.md) | SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM | Nidek Medical Products, Inc. | Jan 23, 1997 | SESE | | [K961867](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K961867.md) | PEEP VALVE | Medical Marketing Concepts | Aug 13, 1996 | SESE | | [K955047](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K955047.md) | WESTMED CIRCULARIE PEP DEVICES | Westmed Intl. | Mar 27, 1996 | SESE | | [K953511](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K953511.md) | KENDALL SHERIDAN CPAP SYSTEM | Kendall Healthcare Products Co. Div.Of Tyco Health | Oct 26, 1995 | SESK | | [K953485](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K953485.md) | SIMS CPAP SYSTEM | Smiths Industries Medical Systems, Inc. | Oct 26, 1995 | SESE | | [K950397](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K950397.md) | SYSTEM 22 VALVE | Turnkey Intergration USA, Inc. | Apr 14, 1995 | SESE | | [K942246](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K942246.md) | PURITAN-BENNETT NASAL CPAP MASK | Puritan-Bennett | Jul 6, 1994 | SESE | | [K932799](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K932799.md) | SINGLE USE MANUAL RESUSCITATOR PEEP VALVE | Engineered Medical Systems | Sep 3, 1993 | SESE | | [K923976](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K923976.md) | AMBU SINGLE PATIENT USE PEEP VALVE | Ambu, Inc. | Jan 5, 1993 | SESE | | [K923618](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K923618.md) | PEEP VALVE | International Respiratory Systems, Inc. | Aug 3, 1992 | SESE | | [K922178](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K922178.md) | COMPANION 318 NASAL CPAP SYSTEM -- MODIFICATION | Puritan Bennett Corp. | May 29, 1992 | SESE | | [K912578](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K912578.md) | 20CM/H20 PEEP VALVE | Vital Signs, Inc. | Sep 11, 1991 | SESE | | [K912240](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K912240.md) | CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM | Mallinckrodt Anesthesia Products | Aug 22, 1991 | SESE | | [K904874](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K904874.md) | ADJUSTABLE PEEP VALVE | Vital Signs, Inc. | Jan 8, 1991 | SESE | | [K903764](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K903764.md) | COMPANION 318 NASAL CPAP SYSTEM | Puritan Bennett Corp. | Sep 10, 1990 | SESE | | [K903125](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K903125.md) | PURITAN BENNETT SINGLE PATIENT USE PEEP VALVE | Puritan Bennett Corp. | Sep 4, 1990 | SESE | | [K902062](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K902062.md) | PEEP VALVE | Hudson Oxygen Therapy Sales Co. | Sep 4, 1990 | SESE | | [K901728](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K901728.md) | ONE-LUNG CPAP DEVICE | Vital Signs, Inc. | Aug 14, 1990 | SESE | | [K900113](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K900113.md) | RESPIRONICS' REMSTAR(TM) SLEEPEASY | Respironics, Inc. | Mar 28, 1990 | SESE | | [K900164](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K900164.md) | AIRWAY DELIVERY & MANAGEMENT (ADAM) NASAL VENTILA. | Puritan Bennett Corp. | Jan 26, 1990 | SESE | | [K894779](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K894779.md) | LIFECARE NASAL MASK KIT CAT. NO. 06-800 | Lifecare Services, Inc. | Jan 12, 1990 | SESE | | [K895360](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K895360.md) | C.P.A.P. VALVE AND C.P.P.A. KIT | Ballard Medical Products | Nov 15, 1989 | SESE | | [K894424](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K894424.md) | DEVILBISS MODEL 7351 SERIES | Devilbiss Health Care, Inc. | Sep 18, 1989 | SESE | | [K894690](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K894690.md) | CPAP MASK | Devilbiss Health Care, Inc. | Sep 8, 1989 | SESE | | [K893388](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K893388.md) | DEVILBISS MODEL 7351D REVITALIZER CPAP SYSTEM | Devilbiss Health Care, Inc. | Jun 23, 1989 | SESE | | [K891540](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K891540.md) | EDENTEC MODEL 2860 PRESSURE METER | Edentec Corp. | Jun 1, 1989 | SESE | | [K883825](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K883825.md) | MODIFIED SANDERS BI-PAPEASY | Respironics, Inc. | Dec 8, 1988 | SESE | | [K882219](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K882219.md) | P.E.E.P. VALVE | Life Support Products, Inc. | Aug 30, 1988 | SESE | | [K881833](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K881833.md) | NASAL CPAP SYSTEM | Healthdyne, Inc. | Jun 24, 1988 | SESE | | [K882292](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K882292.md) | SULLIVAN NASAL CPAP SYSTEM | Baxter Centre For Medical Research | Jun 21, 1988 | SESE | | [K881614](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K881614.md) | MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER) | Ohmeda Medical | Apr 29, 1988 | SESE | | [K880161](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K880161.md) | ACKRAD PEDIATRIC C.P.A.P. SYSTEM | Ackrad Laboratories | Mar 4, 1988 | SESE | | [K875073](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K875073.md) | BREATHE-FREE | Cincinnati Medical Technologies, Inc. | Feb 29, 1988 | SESE | | [K874479](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K874479.md) | MC/CPAP MANIFOLD | Minneapolis Children'S Services Corp. | Dec 30, 1987 | SESE | | [K873170](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K873170.md) | ARIES | Mountain Medical Equipment, Inc. | Sep 25, 1987 | SESE | | [K871693](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K871693.md) | SLEEP APNEA NASAL CPAP SYSTEM | Puritan Bennett Corp. | Sep 15, 1987 | SESE | | [K872202](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K872202.md) | ADJUSTABLE PEEP VALVE | Med Air Technology, Inc. | Sep 1, 1987 | SESE | | [K871523](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K871523.md) | RESPIRONICS SANDERS BIPAPEASY | Respironics, Inc. | Jul 16, 1987 | SESE | | [K861758](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K861758.md) | CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA | Life Design Systems, Inc. | Jul 14, 1986 | SESE | | [K860848](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K860848.md) | VITAL FLOW NASAL CPAP SYSTEM | Systems 2000, Inc. | Jun 12, 1986 | SESE | | [K861104](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K861104.md) | VARIABLE HIGH FLOW DOWNS CPAP GENERATOR | Med Air Technology, Inc. | Apr 28, 1986 | SESE | | [K854822](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K854822.md) | LDS PEEP VALVE | Life Design Systems, Inc. | Feb 24, 1986 | SESE | | [K854458](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K854458.md) | CUSHION-FLEX TM-CPAP FACE MASK | Life Design Systems, Inc. | Jan 15, 1986 | SESE | | [K851396](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K851396.md) | SANDER'S MASKCPAP BY RESPIRONICS | Respironics, Inc. | May 15, 1985 | SESE | | [K851194](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K851194.md) | AMBU CPAP SYSTEM | Ambu, Inc. | Apr 15, 1985 | SESE | | [K843889](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K843889.md) | RESPIRONICS SLEEPEASY NASAL CPAP SYS | Respironics, Inc. | Dec 4, 1984 | SESE | | [K843835](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K843835.md) | OHMEDA PEEP VALVE FOR GMS ABSORBER | Ohmeda Medical | Nov 15, 1984 | SESE | | [K834085](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K834085.md) | DRAGER PEEP SYSTEM D | Draeger Medical, Inc. | Dec 16, 1983 | SESE | | [K831503](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K831503.md) | DOWNS ADJUSTABLE FLOW GENERATOR | Vital Signs, Inc. | Sep 12, 1983 | SESE | | [K831301](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K831301.md) | PEEP SYSTEM D | Draeger Medical, Inc. | Jun 8, 1983 | SESE | | [K830395](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K830395.md) | PEEPER | Dupaco, Inc. | Mar 11, 1983 | SESE | | [K820404](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K820404.md) | PEEP VALVE | Vital Signs, Inc. | Mar 1, 1982 | SESE | | [K802943](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K802943.md) | POSITIVE END EXPIRATORY PRESSURE VALVE | Fraser Harlake, Inc. | Jan 15, 1981 | SESE | | [K802707](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K802707.md) | DRAGER PEEP CONTROL SYSTEM | Draeger Medical, Inc. | Nov 12, 1980 | SESE | | [K802070](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K802070.md) | VITAL SIGNS PEEP VALVE | Vital Signs, Inc. | Sep 9, 1980 | SESE | | [K800755](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K800755.md) | BOEHRINGER LABS AMBULATORY PEEP VALVE | Boehringer Laboratories | May 8, 1980 | SESE | | [K782152](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K782152.md) | VALVE, AMBU PEEP | Narco Air-Shields | Dec 26, 1978 | SESP | | [K781332](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K781332.md) | PEEP/CPAP VALVE | Vickers America Medical Corp. | Oct 4, 1978 | SESE | | [K770766](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K770766.md) | REGULATOR, PRESSURE, EXPIRATORY | Globe Safety Products, Inc. | May 10, 1977 | SESE | | [K760230](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K760230.md) | VALVE, PEEP | Ohio Medical Products | Aug 6, 1976 | SESE | ## Top Applicants - Vital Signs, Inc. — 6 clearances - Respironics, Inc. — 5 clearances - Puritan Bennett Corp. — 5 clearances - Life Design Systems, Inc. — 3 clearances - Draeger Medical, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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