Valve, Non-Rebreathing

FDA product code CBP · 100 cleared devices

Class 2 Anesthesiology

Regulation: 21 CFR 868.5870
Review panel: AN
Implant: No
Life sustaining: Yes
Third party review: Yes
GMP exempt: No
Clearance span: 1977-05-23 – 2024-10-29

CBP 2024-10-29

QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)

Applicant Dehas Medical Systems GmbH

K number K241366

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CBP 2024-08-09

F&P Optiflow Flow Diverter

Applicant Fisher & Paykel Healthcare, Ltd.

K number K234053

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CBP 2021-12-23

Altech® Exhalation Valve (Single Limb and Dual Limb)

Applicant Meditera Tibbi Malzeme San VE Tic AS

K number K210992

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CBP 2020-11-25

CPR Face Shield

Applicant Firstar Healthcare Company Limited (Guangzhou)

K number K192285

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CBP 2019-04-05

OJR215 Pressure Relief Manifold

Applicant Fisher & Paykel Healthcare Limited

K number K173770

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CBP 2017-11-17

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)

Applicant Xiamen Compower Medical Tech. Co., Ltd.

K number K171961

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CBP 2016-06-03

Seal Rite Non-Rebreathing Valve

Applicant The Lifeguard Store, Inc.

K number K152521

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CBP 2011-12-01

GENUINE FIRST AID CPR MASK

Applicant Genuine First Aid, LLC

K number K112126

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CBP 2011-07-28

AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE

Applicant Wet Nose Technologies, LLC

K number K111191

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CBP 2011-03-18

CPR FACE MASK

Applicant Genuine First Aid, LLC

K number K102299

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CBP 2010-07-22

CPR MASK

Applicant Firstar Healthcare Co., Ltd.

K number K083418

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CBP 2010-03-25

PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100

Applicant Wet Nose Technologies, LLC

K number K091538

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CBP 2009-03-13

OXYGEN DEMAND VALVE

Applicant Bpr Medical, Ltd.

K number K082345

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CBP 2008-08-26

MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT

Applicant Medsource International, LLC

K number K081516

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CBP 2006-07-07

LIV MEDICA CPR FACE MASK

Applicant Liv Medica Products Pvt. , Ltd.

K number K052458

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CBP 2005-12-22

DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921

Applicant Dynarex Corp.

K number K052743

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CBP 2005-03-18

POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A

Applicant Foremount Ent. Co., Ltd.

K number K042727

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CBP 2004-07-29

MERLIN E-MASK

Applicant Merlin Medical Limited

K number K031397

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CBP 2004-07-13

BAWMED RESCUE MASK

Applicant Bawmed UK

K number K031431

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CBP 2004-03-04

PRESSURE MANIFOLD, MODEL BC 110

Applicant Fisher & Paykel Healthcare, Ltd.

K number K040366

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CBP 2003-04-22

MODIFICATION TO HIOX

Applicant Sensor Medics Corp.

K number K030943

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CBP 2003-02-11

LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050

Applicant Laerdal Medical A/S

K number K023805

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CBP 2002-07-30

HI-OX

Applicant Sensor Medics Corp.

K number K020665

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CBP 2001-03-14

Y2000 POCKET RESCUE

Applicant Cheen Houng Ent. Co. , Ltd.

K number K010191

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CBP 2000-10-06

RESUSCI INFLATE-A-SHIELD CPR BARRIER

Applicant Laerdal Medical Corp.

K number K001742

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CBP 2000-05-31

RUSCH EMERGENCY MASK

Applicant Rusch, Inc.

K number K993528

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CBP 1999-11-03

FACE-2-FACE CPR PROTECTION SHIELD

Applicant Whiteline Plastics, Inc.

K number K991617

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CBP 1999-07-01

AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P

Applicant Instrumentation Industries, Inc.

K number K983631

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CBP 1999-04-07

EMS MOUTH TO MASK RESUSCITATORS

Applicant Engineered Medical Systems

K number K983919

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CBP 1999-01-29

EXHALATION VALVE

Applicant Intersurgical, Inc.

K number K984481

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CBP 1998-08-24

EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A)

Applicant Instrumentation Industries, Inc.

K number K980725

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CBP 1998-08-05

RESPAIDE

Applicant Emergency Filtration Products, Inc.

K number K980052

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CBP 1998-05-19

RONDEX CPR ISO-SHIELD

Applicant Rondex Products, Inc.

K number K981169

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CBP 1998-02-03

NON-REBREATHING 'T' (BE 117)

Applicant Instrumentation Industries, Inc.

K number K973066

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CBP 1997-09-18

ONE-WAY VALVE (WITH CONNECTOR)

Applicant Instrumentation Industries, Inc.

K number K970780

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CBP 1997-07-21

CPROTECTOR 2000

Applicant Certified Safety Mfg., Inc.

K number K960587

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CBP 1997-04-08

SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR

Applicant Spiracle Technology

K number K963755

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CBP 1997-01-07

CPR BIO-BARRIER FACESHEILD

Applicant O-Two Systems Intl., Inc.

K number K960995

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CBP 1996-10-08

RESCUE BREATHER

Applicant International Safety, Inc.

K number K955520

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CBP 1996-09-16

CPR LIFE MASK COMPACT BARRIER

Applicant Carefree Trading, Inc.

K number K954426

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CBP 1996-06-10

MONTGOMERY TRACHEOSTOMY SPEAKING VALVE

Applicant Boston Medical Products, Inc.

K number K955634

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CBP 1996-03-20

CPR MICROMASK WITH OXYGEN INLET

Applicant Plasco, Inc.

K number K953414

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CBP 1996-02-29

SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE

Applicant Spiracle Technology

K number K953349

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CBP 1996-02-14

CPR SUPER POCKET PACK

Applicant Formosa-Cj Health Business Corp.

K number K953230

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CBP 1996-01-04

CPR MASK & RELATED FAMILY KITS

Applicant Safetec of America, Inc.

K number K953461

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CBP 1995-10-19

CPR MICROMASK

Applicant Plasco, Inc.

K number K951483

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CBP 1995-09-25

PERSHIELD CPR DEVICE

Applicant Rabintex Industries, Ltd.

K number K940820

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CBP 1995-05-25

3M FILTRETE(TM) AIR FILTER MEDIA

Applicant Tagg Industries

K number K946225

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CBP 1995-03-23

MOUTH-TO-MASK RESUSCITATOR

Applicant Mtm Health Products , Ltd.

K number K940503

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CBP 1995-03-10

CPR MICROSHIELD II

Applicant Plasco, Inc.

K number K950770

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CBP 1995-03-10

CPR MICROMASK PLUS CATALOG NO 73-402

Applicant Plasco, Inc.

K number K950769

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CBP 1995-02-24

CAPNO-FLO(TM) REGULATOR

Applicant Kirk Specialty Systems

K number K945822

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CBP 1995-02-21

4-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050

Applicant Cal West Trading Co.

K number K950392

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CBP 1995-02-21

CPR MICROMASK

Applicant Plasco, Inc.

K number K943386

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CBP 1995-02-07

CPR SHIELD

Applicant Rondex Products, Inc.

K number K942671

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CBP 1994-11-14

PPM III

Applicant O-Two Systems Intl., Inc.

K number K940712

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CBP 1994-11-10

NON-BREATHING VALVE

Applicant Rondex Products, Inc.

K number K943761

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CBP 1994-11-10

COMPLETE CPR KIT

Applicant Mtm Health Products , Ltd.

K number K941008

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CBP 1994-11-01

4-O2 JR. (CPR MOUTH BARRIER)

Applicant Eagle Health Supplies

K number K945177

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CBP 1994-10-31

PROTECTAIDE CPR PROTECTION PACK

Applicant Protectaide, Inc.

K number K942469

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CBP 1994-10-31

PROTECTAIDE CPR PROTECTION PACK NO. 22100

Applicant Protectaide, Inc.

K number K942468

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CBP 1994-10-14

RESCUE BREATHER

Applicant O-Two Systems Intl., Inc.

K number K940927

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CBP 1994-10-06

PROTECTAIDE AVIATOR CPR PROTECTION PACK NO. 31000

Applicant Protectaide, Inc.

K number K942467

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CBP 1994-10-06

PROTECTAIDE CPR PROTECTION PACK NO. 17701

Applicant Protectaide, Inc.

K number K942466

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CBP 1994-08-19

K.P.R. (KING PERSONAL RESUSCITATOR)

Applicant King Systems Corp.

K number K943402

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CBP 1994-06-22

MOUTH TO MOUTH BREATHER

Applicant Gam Industries, Inc.

K number K942021

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CBP 1994-01-06

CPROTECTOR

Applicant Certified Safety Mfg., Inc.

K number K934821

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CBP 1994-01-05

MAGNASHIELD CPR MOUTH BARRIER

Applicant Cal West Trading Co.

K number K933756

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CBP 1992-02-03

NON REBREATHING VALVE

Applicant Specialty Packaging Producs, Inc.

K number K913163

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CBP 1991-11-08

RONDEX CPR NON REBREATHING VALVE #9030, MODIFIED

Applicant Rondex Products, Inc.

K number K914195

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CBP 1990-10-26

CPR VALVE (NON-REBREATHING) MODEL #9030

Applicant Rondex Products, Inc.

K number K902299

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CBP 1989-10-13

NON-REBREATHING AIRWAY AND MASK(S) KITS

Applicant Airway Products, Inc.

K number K891124

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CBP 1988-12-13

LSP DEMAND INHALATOR VALVE MODEL SPOO68 W/MASK

Applicant Sechrist Industries, Inc.

K number K884543

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CBP 1988-11-21

LIFEGUARD VENT MASK

Applicant Breath of Life, Inc.

K number K883383

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CBP 1988-10-07

NON-REBREATHING TEE PIECE (NRTP)

Applicant Dhd Medical Products Div. Diemolding Corp.

K number K883988

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CBP 1988-07-21

RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR

Applicant Rondex Products, Inc.

K number K881931

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CBP 1988-07-08

RESUSCITATOR VALVE ASSEMBLY W/FILTER

Applicant Intertech/Ohio

K number K882204

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CBP 1987-11-30

LIFECARE EXHALATION VALVE #06-699

Applicant Lifecare Services, Inc.

K number K873570

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CBP 1987-06-19

HY-FLOW NON-REBREATHING VALVE ASSEMBLY

Applicant Med Air Technology, Inc.

K number K871367

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CBP 1987-05-21

CARHILL ONE-WAY RESUSCITATION VALVE

Applicant Life Design Systems, Inc.

K number K864681

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CBP 1987-05-04

NO. 1552, VALVED VENTI-COMP

Applicant Hudson Oxygen Therapy Sales Co.

K number K870895

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CBP 1987-03-06

DRV DISP RESUSCIT 3000/BAG ADAPT 3010 & 3011

Applicant Nova-Ventrx

K number K870382

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CBP 1987-03-06

INSPIRON(R) BREATH FOR LIFE EMERG. RESUSCITATOR

Applicant Intertech Resources, Inc.

K number K870253

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CBP 1987-03-06

1160 SIMPLE ISOLATION VALVE & 1161 FILTERED VALVE

Applicant Hudson Oxygen Therapy Sales Co.

K number K870138

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CBP 1987-01-12

PERSON TO PERSON VALVE-MASK & TRI-SEAL FACE MASK

Applicant Tagg Industries

K number K864472

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CBP 1986-05-21

LAERDAL POCKET MASK

Applicant Laerdal Medical Corp.

K number K861401

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CBP 1986-02-12

RONDEX CPR VALVE

Applicant Kondex Products, Inc.

K number K855218

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CBP 1983-12-08

RESCUE VALVE

Applicant Respironics, Inc.

K number K833748

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CBP 1983-09-26

RESUSCITATION VALVE

Applicant Boehringer Laboratories

K number K832868

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CBP 1983-07-26

WHISTLER IN-LINE PRESSURE RELEASE VALVE

Applicant Airlife, Inc.

K number K831246

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CBP 1981-02-23

CM 3

Applicant Instrumentation Industries, Inc.

K number K810348

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CBP 1979-10-09

RETARD VALVE 3-STACK #M-514

Applicant Mem Medical, Inc.

K number K791908

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CBP 1979-10-09

RETARD VALVE 3-STACK #M-515

Applicant Mem Medical, Inc.

K number K791907

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CBP 1979-10-01

ONE-WAY VALVE-FEMALE, M-503

Applicant Mem Medical, Inc.

K number K791850

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CBP 1979-10-01

ONE-WAY VALVE-MALE, M-504

Applicant Mem Medical, Inc.

K number K791849

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CBP 1979-05-04

NON-REBREATHING T PIECE

Applicant Dhd Medical Products Div. Diemolding Corp.

K number K790820

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CBP 1979-03-12

ONE-WAY VALVE

Applicant Airlife, Inc.

K number K790151

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CBP 1978-12-04

VALVE, VENT-AWAY TWO-WAY

Applicant Chesebrough-Pond'S U.S.A. Co.

K number K781920

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CBP 1977-05-23

VALVE, EXHALATION BE 115-4, 115-5

Applicant Instrumentation Industries, Inc.

K number K770629

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CBP 1977-05-23

ADAPTER, VALVE, ONE WAY BE-130-22

Applicant Instrumentation Industries, Inc.

K number K770627

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