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
K790151 AIRLIFE, INC. ONE-WAY VALVE 03/12/1979
K831246 AIRLIFE, INC. WHISTLER IN-LINE PRESSURE RELEASE VALVE 07/26/1983
K891124 AIRWAY PRODUCTS, INC. NON-REBREATHING AIRWAY AND MASK(S) KITS 10/13/1989
K031431 BAWMED UK BAWMED RESCUE MASK 07/13/2004
K832868 BOEHRINGER LABORATORIES RESUSCITATION VALVE 09/26/1983
K955634 BOSTON MEDICAL PRODUCTS, INC. MONTGOMERY TRACHEOSTOMY SPEAKING VALVE 06/10/1996
K082345 BPR MEDICAL, LTD. OXYGEN DEMAND VALVE 03/13/2009
K883383 BREATH OF LIFE, INC. LIFEGUARD VENT MASK 11/21/1988
K950392 CAL WEST TRADING CO. 4-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050 02/21/1995
K933756 CAL WEST TRADING CO. MAGNASHIELD CPR MOUTH BARRIER 01/05/1994
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
K781920 CHESEBROUGH-POND'S U.S.A. CO. VALVE, VENT-AWAY TWO-WAY 12/04/1978
K790820 DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. NON-REBREATHING "T" PIECE 05/04/1979
K883988 DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. NON-REBREATHING TEE PIECE (NRTP) 10/07/1988
K052743 DYNAREX CORP. DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 12/22/2005
K945177 EAGLE HEALTH SUPPLIES 4-O2 JR. (CPR MOUTH BARRIER) 11/01/1994
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
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
K942021 GAM INDUSTRIES, INC. MOUTH TO MOUTH BREATHER 06/22/1994
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
K870138 HUDSON OXYGEN THERAPY SALES CO. 1160 SIMPLE ISOLATION VALVE & 1161 FILTERED VALVE 03/06/1987
K870895 HUDSON OXYGEN THERAPY SALES CO. NO. 1552, VALVED VENTI-COMP 05/04/1987
K770627 INSTRUMENTATION INDUSTRIES, INC. ADAPTER, VALVE, ONE WAY BE-130-22 05/23/1977
K983631 INSTRUMENTATION INDUSTRIES, INC. AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P 07/01/1999
K810348 INSTRUMENTATION INDUSTRIES, INC. CM 3 02/23/1981
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
K770629 INSTRUMENTATION INDUSTRIES, INC. VALVE, EXHALATION BE 115-4, 115-5 05/23/1977
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
K870253 INTERTECH RESOURCES, INC. INSPIRON(R) "BREATH FOR LIFE" EMERG. RESUSCITATOR 03/06/1987
K882204 INTERTECH/OHIO RESUSCITATOR VALVE ASSEMBLY W/FILTER 07/08/1988
K943402 KING SYSTEMS CORP. K.P.R. (KING PERSONAL RESUSCITATOR) 08/19/1994
K945822 KIRK SPECIALTY SYSTEMS CAPNO-FLO(TM) REGULATOR 02/24/1995
K855218 KONDEX PRODUCTS, INC. RONDEX CPR VALVE 02/12/1986
K023805 LAERDAL MEDICAL A/S LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050 02/11/2003
K861401 LAERDAL MEDICAL CORP. LAERDAL POCKET MASK 05/21/1986
K001742 LAERDAL MEDICAL CORP. RESUSCI INFLATE-A-SHIELD CPR BARRIER 10/06/2000
K864681 LIFE DESIGN SYSTEMS, INC. CARHILL ONE-WAY RESUSCITATION VALVE 05/21/1987
K873570 LIFECARE SERVICES, INC. LIFECARE EXHALATION VALVE #06-699 11/30/1987
K052458 LIV MEDICA PRODUCTS PVT. LTD. LIV MEDICA CPR FACE MASK 07/07/2006
K871367 MED AIR TECHNOLOGY, INC. "HY-FLOW" NON-REBREATHING VALVE ASSEMBLY 06/19/1987
K081516 MEDSOURCE INTERNATIONAL, LLC. MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT 08/26/2008
K791850 MEM MEDICAL, INC. ONE-WAY VALVE-FEMALE, M-503 10/01/1979
K791849 MEM MEDICAL, INC. ONE-WAY VALVE-MALE, M-504 10/01/1979
K791908 MEM MEDICAL, INC. RETARD VALVE 3-STACK #M-514 10/09/1979
K791907 MEM MEDICAL, INC. RETARD VALVE 3-STACK #M-515 10/09/1979
K031397 MERLIN MEDICAL LIMITED MERLIN E-MASK 07/29/2004
K941008 MTM HEALTH PRODUCTS LTD. COMPLETE CPR KIT 11/10/1994
K940503 MTM HEALTH PRODUCTS LTD. MOUTH-TO-MASK RESUSCITATOR 03/23/1995
K870382 NOVA-VENTRX DRV DISP RESUSCIT 3000/BAG ADAPT 3010 & 3011 03/06/1987
K960995 O-TWO SYSTEMS INTL., INC. CPR BIO-BARRIER FACESHEILD 01/07/1997
K940712 O-TWO SYSTEMS INTL., INC. PPM III 11/14/1994
K951483 PLASCO, INC. CPR MICROMASK 10/19/1995
K950769 PLASCO, INC. CPR MICROMASK PLUS CATALOG NO 73-402 03/10/1995
K953414 PLASCO, INC. CPR MICROMASK WITH OXYGEN INLET 03/20/1996
K950770 PLASCO, INC. CPR MICROSHIELD II 03/10/1995
K940820 RABINTEX INDUSTRIES, LTD. PERSHIELD CPR DEVICE 09/25/1995
K833748 RESPIRONICS, INC. RESCUE VALVE 12/08/1983
K902299 RONDEX PRODUCTS, INC. CPR VALVE (NON-REBREATHING) MODEL #9030 10/26/1990
K943761 RONDEX PRODUCTS, INC. NON-BREATHING VALVE 11/10/1994
K881931 RONDEX PRODUCTS, INC. RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR 07/21/1988
K914195 RONDEX PRODUCTS, INC. RONDEX CPR NON REBREATHING VALVE #9030, MODIFIED 11/08/1991
K993528 RUSCH, INC. RUSCH EMERGENCY MASK 05/31/2000
K953461 SAFETEC OF AMERICA, INC. CPR MASK & RELATED FAMILY KITS 01/04/1996
K884543 SECHRIST INDUSTRIES, INC. LSP DEMAND INHALATOR VALVE MODEL SPOO68 W/MASK 12/13/1988
K030943 SENSOR MEDICS CORP. MODIFICATION TO HIOX 04/22/2003
K020665 SENSORMEDICS CORP. HI-OX 07/30/2002
K913163 SPECIALTY PACKAGING PRODUCS, INC. NON REBREATHING VALVE 02/03/1992
K963755 SPIRACLE TECHNOLOGY SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR 04/08/1997
K953349 SPIRACLE TECHNOLOGY SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE 02/29/1996
K946225 TAGG INDUSTRIES 3M FILTRETE(TM) AIR FILTER MEDIA 05/25/1995
K864472 TAGG INDUSTRIES PERSON TO PERSON VALVE-MASK & TRI-SEAL FACE MASK 01/12/1987
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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