FDA 510(k) Applications for Medical Device Product Code "CBP"
(Valve, Non-Rebreathing)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K142402 | 12th Man Technologies, Inc. | BigEasy Non-Rebreathing Valve | 03/23/2015 |
| K031431 | BAWMED UK | BAWMED RESCUE MASK | 07/13/2004 |
| K955634 | BOSTON MEDICAL PRODUCTS, INC. | MONTGOMERY TRACHEOSTOMY SPEAKING VALVE | 06/10/1996 |
| K082345 | BPR MEDICAL, LTD. | OXYGEN DEMAND VALVE | 03/13/2009 |
| K954426 | CAREFREE TRADING, INC. | CPR LIFE MASK COMPACT BARRIER | 09/16/1996 |
| K960587 | CERTIFIED SAFETY MFG., INC. | CPROTECTOR 2000 | 07/21/1997 |
| K010191 | CHEEN HOUNG ENT. CO. LTD. | Y2000 POCKET RESCUE | 03/14/2001 |
| K052743 | DYNAREX CORP. | DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 | 12/22/2005 |
| K980052 | EMERGENCY FILTRATION PRODUCTS, INC. | RESPAIDE | 08/05/1998 |
| K983919 | ENGINEERED MEDICAL SYSTEMS | EMS MOUTH TO MASK RESUSCITATORS | 04/07/1999 |
| K083418 | FIRSTAR HEALTHCARE CO., LTD. | CPR MASK | 07/22/2010 |
| K192285 | Firstar Healthcare Company Limited (Guangzhou) | CPR Face Shield | 11/25/2020 |
| K173770 | Fisher & Paykel Healthcare Limited | OJR215 Pressure Relief Manifold | 04/05/2019 |
| K040366 | FISHER & PAYKEL HEALTHCARE, LTD. | PRESSURE MANIFOLD, MODEL BC 110 | 03/04/2004 |
| K042727 | FOREMOUNT ENT. CO., LTD. | POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A | 03/18/2005 |
| K953230 | FORMOSA-CJ HEALTH BUSINESS CORP. | CPR SUPER POCKET PACK | 02/14/1996 |
| K102299 | GENUINE FIRST AID LLC | CPR FACE MASK | 03/18/2011 |
| K112126 | GENUINE FIRST AID LLC | GENUINE FIRST AID CPR MASK | 12/01/2011 |
| K142764 | HANGZHOU JINLIN MEDICAL APPLIANCES CO., LTD. | KYOLING CPR Mask with Oxygen Port and Without Oxygen Port | 07/09/2015 |
| K983631 | INSTRUMENTATION INDUSTRIES, INC. | AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P | 07/01/1999 |
| K980725 | INSTRUMENTATION INDUSTRIES, INC. | EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A) | 08/24/1998 |
| K973066 | INSTRUMENTATION INDUSTRIES, INC. | NON-REBREATHING 'T' (BE 117) | 02/03/1998 |
| K970780 | INSTRUMENTATION INDUSTRIES, INC. | ONE-WAY VALVE (WITH CONNECTOR) | 09/18/1997 |
| K955520 | INTERNATIONAL SAFETY, INC. | RESCUE BREATHER | 10/08/1996 |
| K132143 | INTERSURGICAL INCORPORATED | EXHALATION VALVE | 06/04/2014 |
| K984481 | INTERSURGICAL, INC. | EXHALATION VALVE | 01/29/1999 |
| K023805 | LAERDAL MEDICAL A/S | LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050 | 02/11/2003 |
| K001742 | LAERDAL MEDICAL CORP. | RESUSCI INFLATE-A-SHIELD CPR BARRIER | 10/06/2000 |
| K052458 | LIV MEDICA PRODUCTS PVT. LTD. | LIV MEDICA CPR FACE MASK | 07/07/2006 |
| K210992 | Meditera Tibbi Malzeme San Ve TIC AS | Altech« Exhalation Valve (Single Limb and Dual Limb) | 12/23/2021 |
| K081516 | MEDSOURCE INTERNATIONAL, LLC. | MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT | 08/26/2008 |
| K031397 | MERLIN MEDICAL LIMITED | MERLIN E-MASK | 07/29/2004 |
| K960995 | O-TWO SYSTEMS INTL., INC. | CPR BIO-BARRIER FACESHEILD | 01/07/1997 |
| K953414 | PLASCO, INC. | CPR MICROMASK WITH OXYGEN INLET | 03/20/1996 |
| K981169 | RONDEX PRODUCTS, INC. | RONDEX CPR ISO-SHIELD | 05/19/1998 |
| K993528 | RUSCH, INC. | RUSCH EMERGENCY MASK | 05/31/2000 |
| K953461 | SAFETEC OF AMERICA, INC. | CPR MASK & RELATED FAMILY KITS | 01/04/1996 |
| K030943 | SENSOR MEDICS CORP. | MODIFICATION TO HIOX | 04/22/2003 |
| K020665 | SENSORMEDICS CORP. | HI-OX | 07/30/2002 |
| K963755 | SPIRACLE TECHNOLOGY | SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR | 04/08/1997 |
| K953349 | SPIRACLE TECHNOLOGY | SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE | 02/29/1996 |
| K152521 | The Lifeguard Store, Inc. | Seal Rite Non-Rebreathing Valve | 06/03/2016 |
| K111191 | WET NOSE TECHNOLOGIES, LLC | AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE | 07/28/2011 |
| K091538 | WET NOSE TECHNOLOGIES, LLC | PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100 | 03/25/2010 |
| K991617 | WHITELINE PLASTICS, INC. | FACE-2-FACE CPR PROTECTION SHIELD | 11/03/1999 |
| K171961 | Xiamen Compower Medical Tech. Co. Ltd. | 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) | 11/17/2017 |
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