Panels › Anesthesiology › Product code CBP · Class 2
Valve, Non-Rebreathing
Regulation 868.5870
0510(k)s in 12 months (103 all time)
0recalls in 12 months (7 all time)
3recalls that name a 510(k)
Top companies in CBP
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 29, 2024 | K241366 | QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) Dehas Medical Systems GmbH, DE | CBP |
| Aug 9, 2024 | K234053 | F&P Optiflow Flow Diverter Fisher & Paykel Healthcare, Ltd., NZ | CBP |
| Dec 23, 2021 | K210992 | Altech® Exhalation Valve (Single Limb and Dual Limb) Meditera Tibbi Malzeme San VE Tic AS, TR | CBP |
| Nov 25, 2020 | K192285 | CPR Face Shield Firstar Healthcare Company Limited (Guangzhou), CN | CBP |
| Apr 5, 2019 | K173770 | OJR215 Pressure Relief Manifold Fisher & Paykel Healthcare Limited, NZ | CBP |
| Nov 17, 2017 | K171961 | Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebrea Xiamen Compower Medical Tech. Co., Ltd., CN | CBP |
| Jun 3, 2016 | K152521 | Seal Rite Non-Rebreathing Valve The Lifeguard Store, Inc. | CBP |
| Jul 9, 2015 | K142764 | KYOLING CPR Mask with Oxygen Port and Without Oxygen Port Hangzhou Jinlin Medical Appliances Co., Ltd., CN | CBP |
| Mar 23, 2015 | K142402 | BigEasy Non-Rebreathing Valve 12th Man Technologies, Inc. | CBP |
| Jun 4, 2014 | K132143 | EXHALATION VALVE Intersurgical Incorporated | CBP |
| Dec 1, 2011 | K112126 | GENUINE FIRST AID CPR MASK Genuine First Aid, LLC | CBP |
| Jul 28, 2011 | K111191 | AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE Wet Nose Technologies, LLC | CBP |
| Mar 18, 2011 | K102299 | CPR FACE MASK Genuine First Aid, LLC | CBP |
| Jul 22, 2010 | K083418 | CPR MASK Firstar Healthcare Co., Ltd. | CBP |
| Mar 25, 2010 | 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 | CBP |
| Mar 13, 2009 | K082345 | OXYGEN DEMAND VALVE Bpr Medical, Ltd., GB | CBP |
| Aug 26, 2008 | K081516 | MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT Medsource International, LLC | CBP |
| Jul 7, 2006 | K052458 | LIV MEDICA CPR FACE MASK Liv Medica Products Pvt. , Ltd. | CBP |
| Dec 22, 2005 | K052743 | DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 Dynarex Corp. | CBP |
| Mar 18, 2005 | K042727 | POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A Foremount Ent. Co., Ltd., TW | CBP |
| Jul 29, 2004 | K031397 | MERLIN E-MASK Merlin Medical Limited, GB | CBP |
| Jul 13, 2004 | K031431 | BAWMED RESCUE MASK Bawmed UK, GB | CBP |
| Mar 4, 2004 | K040366 | PRESSURE MANIFOLD, MODEL BC 110 Fisher & Paykel Healthcare, Ltd., NZ | CBP |
| Apr 22, 2003 | K030943 | MODIFICATION TO HIOX Sensor Medics Corp. | CBP |
| Feb 11, 2003 | K023805 | LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050 Laerdal Medical A/S, NO | CBP |
| Jul 30, 2002 | K020665 | HI-OX Sensor Medics Corp. | CBP |
| Mar 14, 2001 | K010191 | Y2000 POCKET RESCUE Cheen Houng Ent. Co. , Ltd., TW | CBP |
| Oct 6, 2000 | K001742 | RESUSCI INFLATE-A-SHIELD CPR BARRIER Laerdal Medical Corp. | CBP |
| May 31, 2000 | K993528 | RUSCH EMERGENCY MASK Rusch, Inc. | CBP |
| Nov 3, 1999 | K991617 | FACE-2-FACE CPR PROTECTION SHIELD Whiteline Plastics, Inc., CA | CBP |
| Jul 1, 1999 | K983631 | AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P Instrumentation Industries, Inc. | CBP |
| Apr 7, 1999 | K983919 | EMS MOUTH TO MASK RESUSCITATORS Engineered Medical Systems | CBP |
| Jan 29, 1999 | K984481 | EXHALATION VALVE Intersurgical, Inc. | CBP |
| Aug 24, 1998 | K980725 | EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A) Instrumentation Industries, Inc. | CBP |
| Aug 5, 1998 | K980052 | RESPAIDE Emergency Filtration Products, Inc. | CBP |
| May 19, 1998 | K981169 | RONDEX CPR ISO-SHIELD Rondex Products, Inc. | CBP |
| Feb 3, 1998 | K973066 | NON-REBREATHING 'T' (BE 117) Instrumentation Industries, Inc. | CBP |
| Sep 18, 1997 | K970780 | ONE-WAY VALVE (WITH CONNECTOR) Instrumentation Industries, Inc. | CBP |
| Jul 21, 1997 | K960587 | CPROTECTOR 2000 Certified Safety Mfg., Inc. | CBP |
| Apr 8, 1997 | K963755 | SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR Spiracle Technology | CBP |
| Jan 7, 1997 | K960995 | CPR BIO-BARRIER FACESHEILD O-Two Systems Intl., Inc., CA | CBP |
| Oct 8, 1996 | K955520 | RESCUE BREATHER International Safety, Inc. | CBP |
| Sep 16, 1996 | K954426 | CPR LIFE MASK COMPACT BARRIER Carefree Trading, Inc. | CBP |
| Jun 10, 1996 | K955634 | MONTGOMERY TRACHEOSTOMY SPEAKING VALVE Boston Medical Products, Inc. | CBP |
| Mar 20, 1996 | K953414 | CPR MICROMASK WITH OXYGEN INLET Plasco, Inc. | CBP |
| Feb 29, 1996 | K953349 | SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE Spiracle Technology | CBP |
| Feb 14, 1996 | K953230 | CPR SUPER POCKET PACK Formosa-Cj Health Business Corp. | CBP |
| Jan 4, 1996 | K953461 | CPR MASK & RELATED FAMILY KITS Safetec of America, Inc. | CBP |
| Oct 19, 1995 | K951483 | CPR MICROMASK Plasco, Inc. | CBP |
| Sep 25, 1995 | K940820 | PERSHIELD CPR DEVICE Rabintex Industries, Ltd., IL | CBP |
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