Product code CBP
- Device name
- Valve, Non-Rebreathing
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5870
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241366 | QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) | Dehas Medical Systems GmbH | 2024-10-29 |
| K234053 | F&P Optiflow Flow Diverter | Fisher & Paykel Healthcare, Ltd. | 2024-08-09 |
| K210992 | Altech® Exhalation Valve (Single Limb and Dual Limb) | Meditera Tibbi Malzeme San VE Tic AS | 2021-12-23 |
| K192285 | CPR Face Shield | Firstar Healthcare Company Limited (Guangzhou) | 2020-11-25 |
| K173770 | OJR215 Pressure Relief Manifold | Fisher & Paykel Healthcare Limited | 2019-04-05 |
| 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. | 2017-11-17 |
| K152521 | Seal Rite Non-Rebreathing Valve | The Lifeguard Store, Inc. | 2016-06-03 |
| K142764 | KYOLING CPR Mask with Oxygen Port and Without Oxygen Port | Hangzhou Jinlin Medical Appliances Co., Ltd. | 2015-07-09 |
| K142402 | BigEasy Non-Rebreathing Valve | 12th Man Technologies, Inc. | 2015-03-23 |
| K132143 | EXHALATION VALVE | Intersurgical Incorporated | 2014-06-04 |
| K112126 | GENUINE FIRST AID CPR MASK | Genuine First Aid, LLC | 2011-12-01 |
| K111191 | AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE | Wet Nose Technologies, LLC | 2011-07-28 |
| K102299 | CPR FACE MASK | Genuine First Aid, LLC | 2011-03-18 |
| K083418 | CPR MASK | Firstar Healthcare Co., Ltd. | 2010-07-22 |
| 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 | 2010-03-25 |
| K082345 | OXYGEN DEMAND VALVE | Bpr Medical, Ltd. | 2009-03-13 |
| K081516 | MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT | Medsource International, LLC | 2008-08-26 |
| K052458 | LIV MEDICA CPR FACE MASK | Liv Medica Products Pvt. , Ltd. | 2006-07-07 |
| K052743 | DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 | Dynarex Corp. | 2005-12-22 |
| K042727 | POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A | Foremount Ent. Co., Ltd. | 2005-03-18 |
| K031397 | MERLIN E-MASK | Merlin Medical Limited | 2004-07-29 |
| K031431 | BAWMED RESCUE MASK | Bawmed UK | 2004-07-13 |
| K040366 | PRESSURE MANIFOLD, MODEL BC 110 | Fisher & Paykel Healthcare, Ltd. | 2004-03-04 |
| K030943 | MODIFICATION TO HIOX | Sensor Medics Corp. | 2003-04-22 |
| K023805 | LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050 | Laerdal Medical A/S | 2003-02-11 |
| K020665 | HI-OX | Sensor Medics Corp. | 2002-07-30 |
| K010191 | Y2000 POCKET RESCUE | Cheen Houng Ent. Co. , Ltd. | 2001-03-14 |
| K001742 | RESUSCI INFLATE-A-SHIELD CPR BARRIER | Laerdal Medical Corp. | 2000-10-06 |
| K993528 | RUSCH EMERGENCY MASK | Rusch, Inc. | 2000-05-31 |
| K991617 | FACE-2-FACE CPR PROTECTION SHIELD | Whiteline Plastics, Inc. | 1999-11-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B448260103 | Xpect | Firstar Healthcare Company Limited (Guangzhou) | 2026-05-13 |
| 10889483570562 | AirLife™ | AIRLIFE | 2025-03-28 |
| B0023000X0 | Rescuer | B.L.S. Systems Limited | 2023-12-11 |
| 09420012445261 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2023-07-06 |
| 10850015055307 | Uline 25 Person First Aid Kit - SUB | ULINE, INC. | 2022-01-14 |
| 10850015055314 | Uline 50 Person First Aid Kit - SUB | ULINE, INC. | 2022-01-14 |
| 10193489031805 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-11-05 |
| 10884389121269 | Medline | MEDLINE INDUSTRIES, INC. | 2020-11-05 |
| 10612479255170 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-02-14 |
| 10607415001416 | Moore | MOORE MEDICAL LLC | 2017-05-11 |
| 10607415001393 | Moore | MOORE MEDICAL LLC | 2017-05-11 |
| B0022030P0 | Faceshield with one way valve, glove, wipe in pouch | B.L.S. Systems Limited | 2017-02-13 |
| B0023000P0 | Faceshield with valve and filter in keyring pouch | B.L.S. Systems Limited | 2017-02-13 |
| M996NS3011550 | NS 30-115-5 Exhalation Valve | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2017-02-13 |
| M996PS541A0 | PS 54-1A Adapter for Exhalation Valves | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2017-02-11 |
| M996NS30115UL0 | NS 30-115-UL Low Resistance Exhalation Valve | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2017-02-11 |
| M996NS30115U0 | NS 30-115-U Exhalation Valve | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2017-02-11 |
| M996NS301155L0 | NS 30-115-5L Low Resistance Exhalation Valve | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2017-02-11 |
| M996BE30115BL0 | BE 30-115-BL Low Resistance Exhalation Valve | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2017-02-11 |
| M996BE30115B0 | BE 30-115-B Exhalation Valve | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2017-02-11 |
| M996BE195A0 | BE 195-A Adapter for Exhalation Valves | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2017-02-11 |
| 10885403170386 | AirLife | Carefusion Corporation | 2016-08-29 |
| M996BE1310 | BE 131 One-Way Valve | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2015-10-24 |
| M996BE13023BB0 | BE 130-23BB One-Way Valve | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2015-10-24 |
| M996BE13022B0 | BE 130-22B One-way Valve | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2015-10-24 |
| M996BE1300 | BE 130 One-Way Valve | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2015-10-24 |
| M996BE1170 | BE 117 Non-Rebreathing Tee Valve | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2015-10-24 |
| M996KC9P0 | KC 9-P Auto-PEEP Measurement Device | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2015-10-22 |
| 24710810080382 | N/A | GALEMED CORPORATION | 2015-09-24 |
| B00230000 | Faceshield with filter | B.L.S. Systems Limited | 2015-05-07 |