CBP — Valve, Non-Rebreathing Class II
FDA product code CBP covers "Valve, Non-Rebreathing", a Class II medical device regulated under 21 CFR 868.5870. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CBP
- Device Class
- Class II
- Regulation Number
- 868.5870
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K241366 | dehas medical systems | QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MT | October 29, 2024 |
| K234053 | fisher and paykel healthcare | F&P Optiflow Flow Diverter | August 9, 2024 |
| K210992 | meditera tibbi malzeme san ve tic | Altech® Exhalation Valve (Single Limb and Dual Limb) | December 23, 2021 |
| K192285 | firstar healthcare company limited (guangzhou) | CPR Face Shield | November 25, 2020 |
| K173770 | fisher and paykel healthcare limited | OJR215 Pressure Relief Manifold | April 5, 2019 |
| K171961 | xiamen compower medical tech. co | Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compo | November 17, 2017 |
| K152521 | lifeguard store | Seal Rite Non-Rebreathing Valve | June 3, 2016 |
| K142764 | hangzhou jinlin medical appliances co | KYOLING CPR Mask with Oxygen Port and Without Oxygen Port | July 9, 2015 |
| K142402 | 12th man technologies | BigEasy Non-Rebreathing Valve | March 23, 2015 |
| K132143 | intersurgical incorporated | EXHALATION VALVE | June 4, 2014 |
| K112126 | genuine first aid | GENUINE FIRST AID CPR MASK | December 1, 2011 |
| K111191 | wet nose technologies | AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE | July 28, 2011 |
| K102299 | genuine first aid | CPR FACE MASK | March 18, 2011 |
| K083418 | firstar healthcare co | CPR MASK | July 22, 2010 |
| K091538 | wet nose technologies | PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV | March 25, 2010 |
| K082345 | bpr medical | OXYGEN DEMAND VALVE | March 13, 2009 |
| K081516 | medsource international | MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT | August 26, 2008 |
| K052458 | liv medica products pvt. | LIV MEDICA CPR FACE MASK | July 7, 2006 |
| K052743 | dynarex | DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 | December 22, 2005 |
| K042727 | foremount ent. co | POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A | March 18, 2005 |