Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5870](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5870) → CBP — Valve, Non-Rebreathing # CBP · Valve, Non-Rebreathing _Anesthesiology · 21 CFR 868.5870 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP ## Overview - **Product Code:** CBP - **Device Name:** Valve, Non-Rebreathing - **Regulation:** [21 CFR 868.5870](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5870) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) - **3rd-party reviewable:** yes - **Life-sustaining:** yes ## Identification A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 103) Showing 20 most recent of 103 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K241366](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K241366.md) | QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) | Dehas Medical Systems GmbH | Oct 29, 2024 | SESE | | [K234053](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K234053.md) | F&P Optiflow Flow Diverter | Fisher & Paykel Healthcare, Ltd. | Aug 9, 2024 | SESE | | [K210992](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K210992.md) | Altech® Exhalation Valve (Single Limb and Dual Limb) | Meditera Tibbi Malzeme San VE Tic AS | Dec 23, 2021 | SESE | | [K192285](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K192285.md) | CPR Face Shield | Firstar Healthcare Company Limited (Guangzhou) | Nov 25, 2020 | SESE | | [K173770](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K173770.md) | OJR215 Pressure Relief Manifold | Fisher & Paykel Healthcare Limited | Apr 5, 2019 | SESE | | [K171961](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K171961.md) | Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) | Xiamen Compower Medical Tech. Co., Ltd. | Nov 17, 2017 | SESE | | [K152521](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K152521.md) | Seal Rite Non-Rebreathing Valve | The Lifeguard Store, Inc. | Jun 3, 2016 | SESE | | [K142764](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K142764.md) | KYOLING CPR Mask with Oxygen Port and Without Oxygen Port | Hangzhou Jinlin Medical Appliances Co., Ltd. | Jul 9, 2015 | SESE | | [K142402](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K142402.md) | BigEasy Non-Rebreathing Valve | 12th Man Technologies, Inc. | Mar 23, 2015 | SESE | | [K132143](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K132143.md) | EXHALATION VALVE | Intersurgical Incorporated | Jun 4, 2014 | SESE | | [K112126](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K112126.md) | GENUINE FIRST AID CPR MASK | Genuine First Aid, LLC | Dec 1, 2011 | SESE | | [K111191](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K111191.md) | AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE | Wet Nose Technologies, LLC | Jul 28, 2011 | SESE | | [K102299](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K102299.md) | CPR FACE MASK | Genuine First Aid, LLC | Mar 18, 2011 | SESE | | [K083418](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K083418.md) | CPR MASK | Firstar Healthcare Co., Ltd. | Jul 22, 2010 | SESE | | [K091538](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K091538.md) | PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100 | Wet Nose Technologies, LLC | Mar 25, 2010 | SESE | | [K082345](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K082345.md) | OXYGEN DEMAND VALVE | Bpr Medical, Ltd. | Mar 13, 2009 | SESE | | [K081516](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K081516.md) | MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT | Medsource International, LLC | Aug 26, 2008 | SESE | | [K052458](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K052458.md) | LIV MEDICA CPR FACE MASK | Liv Medica Products Pvt. , Ltd. | Jul 7, 2006 | SESE | | [K052743](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K052743.md) | DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 | Dynarex Corp. | Dec 22, 2005 | SESE | | [K042727](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K042727.md) | POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A | Foremount Ent. Co., Ltd. | Mar 18, 2005 | SESE | ## Top Applicants - Instrumentation Industries, Inc. — 7 clearances - Rondex Products, Inc. — 6 clearances - Plasco, Inc. — 5 clearances - Mem Medical, Inc. — 4 clearances - Protectaide, Inc. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP) **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. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com