CBP · Valve, Non-Rebreathing
Anesthesiology · 21 CFR 868.5870 · Class 2
Overview
| Product Code | CBP |
|---|---|
| Device Name | Valve, Non-Rebreathing |
| Regulation | 21 CFR 868.5870 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 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 | QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) | Dehas Medical Systems GmbH | Oct 29, 2024 | SESE |
| K234053 | F&P Optiflow Flow Diverter | Fisher & Paykel Healthcare, Ltd. | Aug 9, 2024 | SESE |
| K210992 | Altech® Exhalation Valve (Single Limb and Dual Limb) | Meditera Tibbi Malzeme San VE Tic AS | Dec 23, 2021 | SESE |
| K192285 | CPR Face Shield | Firstar Healthcare Company Limited (Guangzhou) | Nov 25, 2020 | SESE |
| K173770 | OJR215 Pressure Relief Manifold | Fisher & Paykel Healthcare Limited | Apr 5, 2019 | SESE |
| K171961 | 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 | Seal Rite Non-Rebreathing Valve | The Lifeguard Store, Inc. | Jun 3, 2016 | SESE |
| K142764 | KYOLING CPR Mask with Oxygen Port and Without Oxygen Port | Hangzhou Jinlin Medical Appliances Co., Ltd. | Jul 9, 2015 | SESE |
| K142402 | BigEasy Non-Rebreathing Valve | 12th Man Technologies, Inc. | Mar 23, 2015 | SESE |
| K132143 | EXHALATION VALVE | Intersurgical Incorporated | Jun 4, 2014 | SESE |
| K112126 | GENUINE FIRST AID CPR MASK | Genuine First Aid, LLC | Dec 1, 2011 | SESE |
| K111191 | AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE | Wet Nose Technologies, LLC | Jul 28, 2011 | SESE |
| K102299 | CPR FACE MASK | Genuine First Aid, LLC | Mar 18, 2011 | SESE |
| K083418 | CPR MASK | Firstar Healthcare Co., Ltd. | Jul 22, 2010 | SESE |
| K091538 | 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 | OXYGEN DEMAND VALVE | Bpr Medical, Ltd. | Mar 13, 2009 | SESE |
| K081516 | MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT | Medsource International, LLC | Aug 26, 2008 | SESE |
| K052458 | LIV MEDICA CPR FACE MASK | Liv Medica Products Pvt. , Ltd. | Jul 7, 2006 | SESE |
| K052743 | DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 | Dynarex Corp. | Dec 22, 2005 | SESE |
| K042727 | 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
