Product Code: CBP FDA class 2 21 CFR 868.5870

Valve, Non-Rebreathing

Anesthesiology

The Non-Rebreathing Valve is an anesthesiology device incorporated into a breathing circuit to allow gas to flow in one direction only, preventing the patient from reinhaling exhaled gases and ensuring delivery of fresh gas mixtures during resuscitation or anesthesia. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CBP, regulated under 21 CFR 868.5870, within the Anesthesiology medical specialty. This device is designated as life-sustaining or life-supporting and is eligible for third-party review.

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510(k)s

103

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: CBP
Device Class: FDA class 2
Regulation Number: 868.5870
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 103 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K241366	QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)	Oct 29, 2024	Substantially Equivalent	Dehas Medical Systems GmbH
K234053	F&P Optiflow Flow Diverter	Aug 09, 2024	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K210992	Altech® Exhalation Valve (Single Limb and Dual Limb)	Dec 23, 2021	Substantially Equivalent	Meditera Tibbi Malzeme San VE Tic AS
K192285	CPR Face Shield	Nov 25, 2020	Substantially Equivalent	Firstar Healthcare Company Limited (Guangzhou)
K173770	OJR215 Pressure Relief Manifold	Apr 05, 2019	Substantially Equivalent	Fisher & Paykel Healthcare Limited
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)	Nov 17, 2017	Substantially Equivalent	Xiamen Compower Medical Tech. Co., Ltd.
K152521	Seal Rite Non-Rebreathing Valve	Jun 03, 2016	Substantially Equivalent	The Lifeguard Store, Inc.
K142764	KYOLING CPR Mask with Oxygen Port and Without Oxygen Port	Jul 09, 2015	Substantially Equivalent	Hangzhou Jinlin Medical Appliances Co., Ltd.
K142402	BigEasy Non-Rebreathing Valve	Mar 23, 2015	Substantially Equivalent	12th Man Technologies, Inc.
K132143	EXHALATION VALVE	Jun 04, 2014	Substantially Equivalent	Intersurgical Incorporated
K112126	GENUINE FIRST AID CPR MASK	Dec 01, 2011	Substantially Equivalent	Genuine First Aid, LLC
K111191	AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE	Jul 28, 2011	Substantially Equivalent	Wet Nose Technologies, LLC
K102299	CPR FACE MASK	Mar 18, 2011	Substantially Equivalent	Genuine First Aid, LLC
K083418	CPR MASK	Jul 22, 2010	Substantially Equivalent	Firstar Healthcare Co., Ltd.
K091538	PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100	Mar 25, 2010	Substantially Equivalent	Wet Nose Technologies, LLC
K082345	OXYGEN DEMAND VALVE	Mar 13, 2009	Substantially Equivalent	Bpr Medical, Ltd.
K081516	MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT	Aug 26, 2008	Substantially Equivalent	Medsource International, LLC
K052458	LIV MEDICA CPR FACE MASK	Jul 07, 2006	Substantially Equivalent	Liv Medica Products Pvt. , Ltd.
K052743	DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921	Dec 22, 2005	Substantially Equivalent	Dynarex Corp.
K042727	POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A	Mar 18, 2005	Substantially Equivalent	Foremount Ent. Co., Ltd.
K031397	MERLIN E-MASK	Jul 29, 2004	Substantially Equivalent	Merlin Medical Limited
K031431	BAWMED RESCUE MASK	Jul 13, 2004	Substantially Equivalent	Bawmed UK
K040366	PRESSURE MANIFOLD, MODEL BC 110	Mar 04, 2004	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K030943	MODIFICATION TO HIOX	Apr 22, 2003	Substantially Equivalent	Sensor Medics Corp.
K023805	LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050	Feb 11, 2003	Substantially Equivalent	Laerdal Medical A/S
K020665	HI-OX	Jul 30, 2002	Substantially Equivalent	Sensor Medics Corp.
K010191	Y2000 POCKET RESCUE	Mar 14, 2001	Substantially Equivalent	Cheen Houng Ent. Co. , Ltd.
K001742	RESUSCI INFLATE-A-SHIELD CPR BARRIER	Oct 06, 2000	Substantially Equivalent	Laerdal Medical Corp.
K993528	RUSCH EMERGENCY MASK	May 31, 2000	Substantially Equivalent	Rusch, Inc.
K991617	FACE-2-FACE CPR PROTECTION SHIELD	Nov 03, 1999	Substantially Equivalent	Whiteline Plastics, Inc.
K983631	AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P	Jul 01, 1999	Substantially Equivalent	Instrumentation Industries, Inc.
K983919	EMS MOUTH TO MASK RESUSCITATORS	Apr 07, 1999	Substantially Equivalent	Engineered Medical Systems
K984481	EXHALATION VALVE	Jan 29, 1999	Substantially Equivalent	Intersurgical, Inc.
K980725	EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A)	Aug 24, 1998	Substantially Equivalent	Instrumentation Industries, Inc.
K980052	RESPAIDE	Aug 05, 1998	Substantially Equivalent	Emergency Filtration Products, Inc.
K981169	RONDEX CPR ISO-SHIELD	May 19, 1998	Substantially Equivalent	Rondex Products, Inc.
K973066	NON-REBREATHING 'T' (BE 117)	Feb 03, 1998	Substantially Equivalent	Instrumentation Industries, Inc.
K970780	ONE-WAY VALVE (WITH CONNECTOR)	Sep 18, 1997	Substantially Equivalent	Instrumentation Industries, Inc.
K960587	CPROTECTOR 2000	Jul 21, 1997	Substantially Equivalent	Certified Safety Mfg., Inc.
K963755	SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR	Apr 08, 1997	Substantially Equivalent	Spiracle Technology
K960995	CPR BIO-BARRIER FACESHEILD	Jan 07, 1997	Substantially Equivalent	O-Two Systems Intl., Inc.
K955520	RESCUE BREATHER	Oct 08, 1996	Substantially Equivalent	International Safety, Inc.
K954426	CPR LIFE MASK COMPACT BARRIER	Sep 16, 1996	Unknown	Carefree Trading, Inc.
K955634	MONTGOMERY TRACHEOSTOMY SPEAKING VALVE	Jun 10, 1996	Substantially Equivalent	Boston Medical Products, Inc.
K953414	CPR MICROMASK WITH OXYGEN INLET	Mar 20, 1996	Substantially Equivalent	Plasco, Inc.
K953349	SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE	Feb 29, 1996	Substantially Equivalent	Spiracle Technology
K953230	CPR SUPER POCKET PACK	Feb 14, 1996	Substantially Equivalent	Formosa-Cj Health Business Corp.
K953461	CPR MASK & RELATED FAMILY KITS	Jan 04, 1996	Substantially Equivalent	Safetec of America, Inc.
K951483	CPR MICROMASK	Oct 19, 1995	Substantially Equivalent	Plasco, Inc.
K940820	PERSHIELD CPR DEVICE	Sep 25, 1995	Substantially Equivalent	Rabintex Industries, Ltd.
K946225	3M FILTRETE(TM) AIR FILTER MEDIA	May 25, 1995	Substantially Equivalent	Tagg Industries
K940503	MOUTH-TO-MASK RESUSCITATOR	Mar 23, 1995	Substantially Equivalent	Mtm Health Products , Ltd.
K950770	CPR MICROSHIELD II	Mar 10, 1995	Substantially Equivalent	Plasco, Inc.
K950769	CPR MICROMASK PLUS CATALOG NO 73-402	Mar 10, 1995	Substantially Equivalent	Plasco, Inc.
K945822	CAPNO-FLO(TM) REGULATOR	Feb 24, 1995	Substantially Equivalent	Kirk Specialty Systems
K950392	4-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050	Feb 21, 1995	Substantially Equivalent	Cal West Trading Co.
K943386	CPR MICROMASK	Feb 21, 1995	Substantially Equivalent	Plasco, Inc.
K942671	CPR SHIELD	Feb 07, 1995	Substantially Equivalent	Rondex Products, Inc.
K940712	PPM III	Nov 14, 1994	Substantially Equivalent	O-Two Systems Intl., Inc.
K943761	NON-BREATHING VALVE	Nov 10, 1994	Unknown	Rondex Products, Inc.
K941008	COMPLETE CPR KIT	Nov 10, 1994	Unknown	Mtm Health Products , Ltd.
K945177	4-O2 JR. (CPR MOUTH BARRIER)	Nov 01, 1994	Substantially Equivalent	Eagle Health Supplies
K942469	PROTECTAIDE CPR PROTECTION PACK	Oct 31, 1994	Substantially Equivalent	Protectaide, Inc.
K942468	PROTECTAIDE CPR PROTECTION PACK NO. 22100	Oct 31, 1994	Substantially Equivalent	Protectaide, Inc.
K940927	RESCUE BREATHER	Oct 14, 1994	Substantially Equivalent	O-Two Systems Intl., Inc.
K942467	PROTECTAIDE AVIATOR CPR PROTECTION PACK NO. 31000	Oct 06, 1994	Substantially Equivalent	Protectaide, Inc.
K942466	PROTECTAIDE CPR PROTECTION PACK NO. 17701	Oct 06, 1994	Substantially Equivalent	Protectaide, Inc.
K943402	K.P.R. (KING PERSONAL RESUSCITATOR)	Aug 19, 1994	Substantially Equivalent	King Systems Corp.
K942021	MOUTH TO MOUTH BREATHER	Jun 22, 1994	Substantially Equivalent	Gam Industries, Inc.
K934821	CPROTECTOR	Jan 06, 1994	Substantially Equivalent	Certified Safety Mfg., Inc.
K933756	MAGNASHIELD CPR MOUTH BARRIER	Jan 05, 1994	Substantially Equivalent	Cal West Trading Co.
K913163	NON REBREATHING VALVE	Feb 03, 1992	Substantially Equivalent	Specialty Packaging Producs, Inc.
K914195	RONDEX CPR NON REBREATHING VALVE #9030, MODIFIED	Nov 08, 1991	Substantially Equivalent	Rondex Products, Inc.
K902299	CPR VALVE (NON-REBREATHING) MODEL #9030	Oct 26, 1990	Substantially Equivalent	Rondex Products, Inc.
K891124	NON-REBREATHING AIRWAY AND MASK(S) KITS	Oct 13, 1989	Substantially Equivalent	Airway Products, Inc.
K884543	LSP DEMAND INHALATOR VALVE MODEL SPOO68 W/MASK	Dec 13, 1988	Substantially Equivalent	Sechrist Industries, Inc.
K883383	LIFEGUARD VENT MASK	Nov 21, 1988	Substantially Equivalent	Breath of Life, Inc.
K883988	NON-REBREATHING TEE PIECE (NRTP)	Oct 07, 1988	Substantially Equivalent	Dhd Medical Products Div. Diemolding Corp.
K881931	RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR	Jul 21, 1988	Substantially Equivalent	Rondex Products, Inc.
K882204	RESUSCITATOR VALVE ASSEMBLY W/FILTER	Jul 08, 1988	Substantially Equivalent	Intertech/Ohio
K873570	LIFECARE EXHALATION VALVE #06-699	Nov 30, 1987	Substantially Equivalent	Lifecare Services, Inc.
K871367	HY-FLOW NON-REBREATHING VALVE ASSEMBLY	Jun 19, 1987	Substantially Equivalent	Med Air Technology, Inc.
K864681	CARHILL ONE-WAY RESUSCITATION VALVE	May 21, 1987	Substantially Equivalent	Life Design Systems, Inc.
K870895	NO. 1552, VALVED VENTI-COMP	May 04, 1987	Substantially Equivalent	Hudson Oxygen Therapy Sales Co.
K870382	DRV DISP RESUSCIT 3000/BAG ADAPT 3010 & 3011	Mar 06, 1987	Substantially Equivalent	Nova-Ventrx
K870253	INSPIRON(R) BREATH FOR LIFE EMERG. RESUSCITATOR	Mar 06, 1987	Substantially Equivalent	Intertech Resources, Inc.
K870138	1160 SIMPLE ISOLATION VALVE & 1161 FILTERED VALVE	Mar 06, 1987	Substantially Equivalent	Hudson Oxygen Therapy Sales Co.
K864472	PERSON TO PERSON VALVE-MASK & TRI-SEAL FACE MASK	Jan 12, 1987	Substantially Equivalent	Tagg Industries
K861401	LAERDAL POCKET MASK	May 21, 1986	Substantially Equivalent	Laerdal Medical Corp.
K855218	RONDEX CPR VALVE	Feb 12, 1986	Substantially Equivalent	Kondex Products, Inc.
K833748	RESCUE VALVE	Dec 08, 1983	Substantially Equivalent	Respironics, Inc.
K832868	RESUSCITATION VALVE	Sep 26, 1983	Substantially Equivalent	Boehringer Laboratories
K831246	WHISTLER IN-LINE PRESSURE RELEASE VALVE	Jul 26, 1983	Substantially Equivalent	Airlife, Inc.
K810348	CM 3	Feb 23, 1981	Substantially Equivalent	Instrumentation Industries, Inc.
K791908	RETARD VALVE 3-STACK #M-514	Oct 09, 1979	Substantially Equivalent	Mem Medical, Inc.
K791907	RETARD VALVE 3-STACK #M-515	Oct 09, 1979	Substantially Equivalent	Mem Medical, Inc.
K791850	ONE-WAY VALVE-FEMALE, M-503	Oct 01, 1979	Substantially Equivalent	Mem Medical, Inc.
K791849	ONE-WAY VALVE-MALE, M-504	Oct 01, 1979	Substantially Equivalent	Mem Medical, Inc.
K790820	NON-REBREATHING T PIECE	May 04, 1979	Substantially Equivalent	Dhd Medical Products Div. Diemolding Corp.
K790151	ONE-WAY VALVE	Mar 12, 1979	Substantially Equivalent	Airlife, Inc.
K781920	VALVE, VENT-AWAY TWO-WAY	Dec 04, 1978	Substantially Equivalent	Chesebrough-Pond'S U.S.A. Co.
K770629	VALVE, EXHALATION BE 115-4, 115-5	May 23, 1977	Substantially Equivalent	Instrumentation Industries, Inc.
K770627	ADAPTER, VALVE, ONE WAY BE-130-22	May 23, 1977	Substantially Equivalent	Instrumentation Industries, Inc.