← [Anesthesiology](/submissions/AN) · Product Code CBP # CBP · Valve, Non-Rebreathing _Anesthesiology · 21 CFR 868.5870 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP ## Overview - **Product Code:** CBP - **Device Name:** Valve, Non-Rebreathing - **Regulation:** 21 CFR 868.5870 - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) - **3rd-party reviewable:** yes - **Life-sustaining:** yes ## Identification A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere. ## Classification Rationale Class II (performance standards). ## Cleared Devices (103) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K241366](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K241366.md) | QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) | Dehas Medical Systems GmbH | Oct 29, 2024 | SESE | | [K234053](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K234053.md) | F&P Optiflow Flow Diverter | Fisher & Paykel Healthcare, Ltd. | Aug 9, 2024 | SESE | | [K210992](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K210992.md) | Altech® Exhalation Valve (Single Limb and Dual Limb) | Meditera Tibbi Malzeme San VE Tic AS | Dec 23, 2021 | SESE | | [K192285](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K192285.md) | CPR Face Shield | Firstar Healthcare Company Limited (Guangzhou) | Nov 25, 2020 | SESE | | [K173770](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K173770.md) | OJR215 Pressure Relief Manifold | Fisher & Paykel Healthcare Limited | Apr 5, 2019 | SESE | | [K171961](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K171961.md) | 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. | Nov 17, 2017 | SESE | | [K152521](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K152521.md) | Seal Rite Non-Rebreathing Valve | The Lifeguard Store, Inc. | Jun 3, 2016 | SESE | | [K142764](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K142764.md) | KYOLING CPR Mask with Oxygen Port and Without Oxygen Port | Hangzhou Jinlin Medical Appliances Co., Ltd. | Jul 9, 2015 | SESE | | [K142402](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K142402.md) | BigEasy Non-Rebreathing Valve | 12th Man Technologies, Inc. | Mar 23, 2015 | SESE | | [K132143](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K132143.md) | EXHALATION VALVE | Intersurgical Incorporated | Jun 4, 2014 | SESE | | [K112126](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K112126.md) | GENUINE FIRST AID CPR MASK | Genuine First Aid, LLC | Dec 1, 2011 | SESE | | [K111191](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K111191.md) | AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE | Wet Nose Technologies, LLC | Jul 28, 2011 | SESE | | [K102299](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K102299.md) | CPR FACE MASK | Genuine First Aid, LLC | Mar 18, 2011 | SESE | | [K083418](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K083418.md) | CPR MASK | Firstar Healthcare Co., Ltd. | Jul 22, 2010 | SESE | | [K091538](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K091538.md) | 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 | Mar 25, 2010 | SESE | | [K082345](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K082345.md) | OXYGEN DEMAND VALVE | Bpr Medical, Ltd. | Mar 13, 2009 | SESE | | [K081516](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K081516.md) | MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT | Medsource International, LLC | Aug 26, 2008 | SESE | | [K052458](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K052458.md) | LIV MEDICA CPR FACE MASK | Liv Medica Products Pvt. , Ltd. | Jul 7, 2006 | SESE | | [K052743](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K052743.md) | DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 | Dynarex Corp. | Dec 22, 2005 | SESE | | [K042727](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K042727.md) | POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A | Foremount Ent. Co., Ltd. | Mar 18, 2005 | SESE | | [K031397](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K031397.md) | MERLIN E-MASK | Merlin Medical Limited | Jul 29, 2004 | SESE | | [K031431](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K031431.md) | BAWMED RESCUE MASK | Bawmed UK | Jul 13, 2004 | SESE | | [K040366](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K040366.md) | PRESSURE MANIFOLD, MODEL BC 110 | Fisher & Paykel Healthcare, Ltd. | Mar 4, 2004 | SESE | | [K030943](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K030943.md) | MODIFICATION TO HIOX | Sensor Medics Corp. | Apr 22, 2003 | SESE | | [K023805](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K023805.md) | LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050 | Laerdal Medical A/S | Feb 11, 2003 | SESE | | [K020665](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K020665.md) | HI-OX | Sensor Medics Corp. | Jul 30, 2002 | SESE | | [K010191](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K010191.md) | Y2000 POCKET RESCUE | Cheen Houng Ent. Co. , Ltd. | Mar 14, 2001 | SESE | | [K001742](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K001742.md) | RESUSCI INFLATE-A-SHIELD CPR BARRIER | Laerdal Medical Corp. | Oct 6, 2000 | SESE | | [K993528](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K993528.md) | RUSCH EMERGENCY MASK | Rusch, Inc. | May 31, 2000 | SESE | | [K991617](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K991617.md) | FACE-2-FACE CPR PROTECTION SHIELD | Whiteline Plastics, Inc. | Nov 3, 1999 | SESE | | [K983631](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K983631.md) | AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P | Instrumentation Industries, Inc. | Jul 1, 1999 | SESE | | [K983919](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K983919.md) | EMS MOUTH TO MASK RESUSCITATORS | Engineered Medical Systems | Apr 7, 1999 | SESE | | [K984481](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K984481.md) | EXHALATION VALVE | Intersurgical, Inc. | Jan 29, 1999 | SESE | | [K980725](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K980725.md) | EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A) | Instrumentation Industries, Inc. | Aug 24, 1998 | SESE | | [K980052](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K980052.md) | RESPAIDE | Emergency Filtration Products, Inc. | Aug 5, 1998 | SESE | | [K981169](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K981169.md) | RONDEX CPR ISO-SHIELD | Rondex Products, Inc. | May 19, 1998 | SESE | | [K973066](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K973066.md) | NON-REBREATHING 'T' (BE 117) | Instrumentation Industries, Inc. | Feb 3, 1998 | SESE | | [K970780](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K970780.md) | ONE-WAY VALVE (WITH CONNECTOR) | Instrumentation Industries, Inc. | Sep 18, 1997 | SESE | | [K960587](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K960587.md) | CPROTECTOR 2000 | Certified Safety Mfg., Inc. | Jul 21, 1997 | SESE | | [K963755](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K963755.md) | SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR | Spiracle Technology | Apr 8, 1997 | SESE | | [K960995](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K960995.md) | CPR BIO-BARRIER FACESHEILD | O-Two Systems Intl., Inc. | Jan 7, 1997 | SESE | | [K955520](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K955520.md) | RESCUE BREATHER | International Safety, Inc. | Oct 8, 1996 | SESE | | [K954426](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K954426.md) | CPR LIFE MASK COMPACT BARRIER | Carefree Trading, Inc. | Sep 16, 1996 | SESK | | [K955634](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K955634.md) | MONTGOMERY TRACHEOSTOMY SPEAKING VALVE | Boston Medical Products, Inc. | Jun 10, 1996 | SESE | | [K953414](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K953414.md) | CPR MICROMASK WITH OXYGEN INLET | Plasco, Inc. | Mar 20, 1996 | SESE | | [K953349](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K953349.md) | SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE | Spiracle Technology | Feb 29, 1996 | SESE | | [K953230](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K953230.md) | CPR SUPER POCKET PACK | Formosa-Cj Health Business Corp. | Feb 14, 1996 | SESE | | [K953461](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K953461.md) | CPR MASK & RELATED FAMILY KITS | Safetec of America, Inc. | Jan 4, 1996 | SESE | | [K951483](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K951483.md) | CPR MICROMASK | Plasco, Inc. | Oct 19, 1995 | SESE | | [K940820](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K940820.md) | PERSHIELD CPR DEVICE | Rabintex Industries, Ltd. | Sep 25, 1995 | SESE | | [K946225](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K946225.md) | 3M FILTRETE(TM) AIR FILTER MEDIA | Tagg Industries | May 25, 1995 | SESE | | [K940503](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K940503.md) | MOUTH-TO-MASK RESUSCITATOR | Mtm Health Products , Ltd. | Mar 23, 1995 | SESE | | [K950770](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K950770.md) | CPR MICROSHIELD II | Plasco, Inc. | Mar 10, 1995 | SESE | | [K950769](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K950769.md) | CPR MICROMASK PLUS CATALOG NO 73-402 | Plasco, Inc. | Mar 10, 1995 | SESE | | [K945822](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K945822.md) | CAPNO-FLO(TM) REGULATOR | Kirk Specialty Systems | Feb 24, 1995 | SESE | | [K950392](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K950392.md) | 4-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050 | Cal West Trading Co. | Feb 21, 1995 | SESE | | [K943386](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K943386.md) | CPR MICROMASK | Plasco, Inc. | Feb 21, 1995 | SESE | | [K942671](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K942671.md) | CPR SHIELD | Rondex Products, Inc. | Feb 7, 1995 | SESE | | [K940712](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K940712.md) | PPM III | O-Two Systems Intl., Inc. | Nov 14, 1994 | SESE | | [K943761](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K943761.md) | NON-BREATHING VALVE | Rondex Products, Inc. | Nov 10, 1994 | SESK | | [K941008](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K941008.md) | COMPLETE CPR KIT | Mtm Health Products , Ltd. | Nov 10, 1994 | SESK | | [K945177](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K945177.md) | 4-O2 JR. (CPR MOUTH BARRIER) | Eagle Health Supplies | Nov 1, 1994 | SESE | | [K942469](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K942469.md) | PROTECTAIDE CPR PROTECTION PACK | Protectaide, Inc. | Oct 31, 1994 | SESE | | [K942468](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K942468.md) | PROTECTAIDE CPR PROTECTION PACK NO. 22100 | Protectaide, Inc. | Oct 31, 1994 | SESE | | [K940927](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K940927.md) | RESCUE BREATHER | O-Two Systems Intl., Inc. | Oct 14, 1994 | SESE | | [K942467](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K942467.md) | PROTECTAIDE AVIATOR CPR PROTECTION PACK NO. 31000 | Protectaide, Inc. | Oct 6, 1994 | SESE | | [K942466](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K942466.md) | PROTECTAIDE CPR PROTECTION PACK NO. 17701 | Protectaide, Inc. | Oct 6, 1994 | SESE | | [K943402](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K943402.md) | K.P.R. (KING PERSONAL RESUSCITATOR) | King Systems Corp. | Aug 19, 1994 | SESE | | [K942021](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K942021.md) | MOUTH TO MOUTH BREATHER | Gam Industries, Inc. | Jun 22, 1994 | SESE | | [K934821](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K934821.md) | CPROTECTOR | Certified Safety Mfg., Inc. | Jan 6, 1994 | SESE | | [K933756](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K933756.md) | MAGNASHIELD CPR MOUTH BARRIER | Cal West Trading Co. | Jan 5, 1994 | SESE | | [K913163](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K913163.md) | NON REBREATHING VALVE | Specialty Packaging Producs, Inc. | Feb 3, 1992 | SESE | | [K914195](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K914195.md) | RONDEX CPR NON REBREATHING VALVE #9030, MODIFIED | Rondex Products, Inc. | Nov 8, 1991 | SESE | | [K902299](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K902299.md) | CPR VALVE (NON-REBREATHING) MODEL #9030 | Rondex Products, Inc. | Oct 26, 1990 | SESE | | [K891124](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K891124.md) | NON-REBREATHING AIRWAY AND MASK(S) KITS | Airway Products, Inc. | Oct 13, 1989 | SESE | | [K884543](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K884543.md) | LSP DEMAND INHALATOR VALVE MODEL SPOO68 W/MASK | Sechrist Industries, Inc. | Dec 13, 1988 | SESE | | [K883383](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K883383.md) | LIFEGUARD VENT MASK | Breath of Life, Inc. | Nov 21, 1988 | SESE | | [K883988](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K883988.md) | NON-REBREATHING TEE PIECE (NRTP) | Dhd Medical Products Div. Diemolding Corp. | Oct 7, 1988 | SESE | | [K881931](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K881931.md) | RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR | Rondex Products, Inc. | Jul 21, 1988 | SESE | | [K882204](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K882204.md) | RESUSCITATOR VALVE ASSEMBLY W/FILTER | Intertech/Ohio | Jul 8, 1988 | SESE | | [K873570](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K873570.md) | LIFECARE EXHALATION VALVE #06-699 | Lifecare Services, Inc. | Nov 30, 1987 | SESE | | [K871367](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K871367.md) | HY-FLOW NON-REBREATHING VALVE ASSEMBLY | Med Air Technology, Inc. | Jun 19, 1987 | SESE | | [K864681](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K864681.md) | CARHILL ONE-WAY RESUSCITATION VALVE | Life Design Systems, Inc. | May 21, 1987 | SESE | | [K870895](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K870895.md) | NO. 1552, VALVED VENTI-COMP | Hudson Oxygen Therapy Sales Co. | May 4, 1987 | SESE | | [K870382](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K870382.md) | DRV DISP RESUSCIT 3000/BAG ADAPT 3010 & 3011 | Nova-Ventrx | Mar 6, 1987 | SESE | | [K870253](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K870253.md) | INSPIRON(R) BREATH FOR LIFE EMERG. RESUSCITATOR | Intertech Resources, Inc. | Mar 6, 1987 | SESE | | [K870138](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K870138.md) | 1160 SIMPLE ISOLATION VALVE & 1161 FILTERED VALVE | Hudson Oxygen Therapy Sales Co. | Mar 6, 1987 | SESE | | [K864472](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K864472.md) | PERSON TO PERSON VALVE-MASK & TRI-SEAL FACE MASK | Tagg Industries | Jan 12, 1987 | SESE | | [K861401](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K861401.md) | LAERDAL POCKET MASK | Laerdal Medical Corp. | May 21, 1986 | SESE | | [K855218](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K855218.md) | RONDEX CPR VALVE | Kondex Products, Inc. | Feb 12, 1986 | SESE | | [K833748](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K833748.md) | RESCUE VALVE | Respironics, Inc. | Dec 8, 1983 | SESE | | [K832868](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K832868.md) | RESUSCITATION VALVE | Boehringer Laboratories | Sep 26, 1983 | SESE | | [K831246](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K831246.md) | WHISTLER IN-LINE PRESSURE RELEASE VALVE | Airlife, Inc. | Jul 26, 1983 | SESE | | [K810348](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K810348.md) | CM 3 | Instrumentation Industries, Inc. | Feb 23, 1981 | SESE | | [K791908](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K791908.md) | RETARD VALVE 3-STACK #M-514 | Mem Medical, Inc. | Oct 9, 1979 | SESE | | [K791907](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K791907.md) | RETARD VALVE 3-STACK #M-515 | Mem Medical, Inc. | Oct 9, 1979 | SESE | | [K791850](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K791850.md) | ONE-WAY VALVE-FEMALE, M-503 | Mem Medical, Inc. | Oct 1, 1979 | SESE | | [K791849](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K791849.md) | ONE-WAY VALVE-MALE, M-504 | Mem Medical, Inc. | Oct 1, 1979 | SESE | | [K790820](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K790820.md) | NON-REBREATHING T PIECE | Dhd Medical Products Div. Diemolding Corp. | May 4, 1979 | SESE | | [K790151](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K790151.md) | ONE-WAY VALVE | Airlife, Inc. | Mar 12, 1979 | SESE | | [K781920](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K781920.md) | VALVE, VENT-AWAY TWO-WAY | Chesebrough-Pond'S U.S.A. Co. | Dec 4, 1978 | SESE | | [K770629](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K770629.md) | VALVE, EXHALATION BE 115-4, 115-5 | Instrumentation Industries, Inc. | May 23, 1977 | SESE | | [K770627](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K770627.md) | ADAPTER, VALVE, ONE WAY BE-130-22 | Instrumentation Industries, Inc. | May 23, 1977 | SESE | ## Top Applicants - Instrumentation Industries, Inc. — 7 clearances - Rondex Products, Inc. — 6 clearances - Plasco, Inc. — 5 clearances - Protectaide, Inc. — 4 clearances - Mem Medical, Inc. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP