Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5965](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5965) → BYE — Attachment, Breathing, Positive End Expiratory Pressure # 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](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/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). ## Recent Cleared Devices (20 of 80) Showing 20 most recent of 80 cleared devices. | 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 | ## Top Applicants - Vital Signs, Inc. — 6 clearances - Puritan Bennett Corp. — 5 clearances - Respironics, Inc. — 5 clearances - Devilbiss Health Care, 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. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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