Atlas FDA

CBP

103 FDA 510(k) clearances · Product code

151 daysmedian time to decision
309 days90th percentile
103clearances measured

FDA profile

Official device name
Valve, Non-Rebreathing
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5870
Medical specialty
Anesthesiology
Flags
Life-sustaining · Third-party review eligible
Adverse events (MAUDE)
2002: 6 · 2003: 2 · 2004: 1 · 2009: 6 · 2010: 3 · 2014: 11
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) (K241366)Dehas Medical Systems GmbH2024-10-29
F&P Optiflow Flow Diverter (K234053)Fisher & Paykel Healthcare, Ltd.2024-08-09
Altech® Exhalation Valve (Single Limb and Dual Limb) (K210992)Meditera Tibbi Malzeme San VE Tic AS2021-12-23
CPR Face Shield (K192285)Firstar Healthcare Company Limited (Guangzhou)2020-11-25
OJR215 Pressure Relief Manifold (K173770)Fisher & Paykel Healthcare Limited2019-04-05
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) (K171961)Xiamen Compower Medical Tech. Co., Ltd.2017-11-17
Seal Rite Non-Rebreathing Valve (K152521)The Lifeguard Store, Inc.2016-06-03
KYOLING CPR Mask with Oxygen Port and Without Oxygen Port (K142764)Hangzhou Jinlin Medical Appliances Co., Ltd.2015-07-09
BigEasy Non-Rebreathing Valve (K142402)12th Man Technologies, Inc.2015-03-23
EXHALATION VALVE (K132143)Intersurgical Incorporated2014-06-04
GENUINE FIRST AID CPR MASK (K112126)Genuine First Aid, LLC2011-12-01
AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE (K111191)Wet Nose Technologies, LLC2011-07-28
CPR FACE MASK (K102299)Genuine First Aid, LLC2011-03-18
CPR MASK (K083418)Firstar Healthcare Co., Ltd.2010-07-22
PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100 (K091538)Wet Nose Technologies, LLC2010-03-25
OXYGEN DEMAND VALVE (K082345)Bpr Medical, Ltd.2009-03-13
MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT (K081516)Medsource International, LLC2008-08-26
LIV MEDICA CPR FACE MASK (K052458)Liv Medica Products Pvt. , Ltd.2006-07-07
DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 (K052743)Dynarex Corp.2005-12-22
POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A (K042727)Foremount Ent. Co., Ltd.2005-03-18
MERLIN E-MASK (K031397)Merlin Medical Limited2004-07-29
BAWMED RESCUE MASK (K031431)Bawmed UK2004-07-13
PRESSURE MANIFOLD, MODEL BC 110 (K040366)Fisher & Paykel Healthcare, Ltd.2004-03-04
MODIFICATION TO HIOX (K030943)Sensor Medics Corp.2003-04-22
LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050 (K023805)Laerdal Medical A/S2003-02-11
HI-OX (K020665)Sensor Medics Corp.2002-07-30
Y2000 POCKET RESCUE (K010191)Cheen Houng Ent. Co. , Ltd.2001-03-14
RESUSCI INFLATE-A-SHIELD CPR BARRIER (K001742)Laerdal Medical Corp.2000-10-06
RUSCH EMERGENCY MASK (K993528)Rusch, Inc.2000-05-31
FACE-2-FACE CPR PROTECTION SHIELD (K991617)Whiteline Plastics, Inc.1999-11-03
AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P (K983631)Instrumentation Industries, Inc.1999-07-01
EMS MOUTH TO MASK RESUSCITATORS (K983919)Engineered Medical Systems1999-04-07
EXHALATION VALVE (K984481)Intersurgical, Inc.1999-01-29
EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A) (K980725)Instrumentation Industries, Inc.1998-08-24
RESPAIDE (K980052)Emergency Filtration Products, Inc.1998-08-05
RONDEX CPR ISO-SHIELD (K981169)Rondex Products, Inc.1998-05-19
NON-REBREATHING 'T' (BE 117) (K973066)Instrumentation Industries, Inc.1998-02-03
ONE-WAY VALVE (WITH CONNECTOR) (K970780)Instrumentation Industries, Inc.1997-09-18
CPROTECTOR 2000 (K960587)Certified Safety Mfg., Inc.1997-07-21
SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR (K963755)Spiracle Technology1997-04-08
CPR BIO-BARRIER FACESHEILD (K960995)O-Two Systems Intl., Inc.1997-01-07
RESCUE BREATHER (K955520)International Safety, Inc.1996-10-08
CPR LIFE MASK COMPACT BARRIER (K954426)Carefree Trading, Inc.1996-09-16
MONTGOMERY TRACHEOSTOMY SPEAKING VALVE (K955634)Boston Medical Products, Inc.1996-06-10
CPR MICROMASK WITH OXYGEN INLET (K953414)Plasco, Inc.1996-03-20
SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE (K953349)Spiracle Technology1996-02-29
CPR SUPER POCKET PACK (K953230)Formosa-Cj Health Business Corp.1996-02-14
CPR MASK & RELATED FAMILY KITS (K953461)Safetec of America, Inc.1996-01-04
CPR MICROMASK (K951483)Plasco, Inc.1995-10-19
PERSHIELD CPR DEVICE (K940820)Rabintex Industries, Ltd.1995-09-25
3M FILTRETE(TM) AIR FILTER MEDIA (K946225)Tagg Industries1995-05-25
MOUTH-TO-MASK RESUSCITATOR (K940503)Mtm Health Products , Ltd.1995-03-23
CPR MICROSHIELD II (K950770)Plasco, Inc.1995-03-10
CPR MICROMASK PLUS CATALOG NO 73-402 (K950769)Plasco, Inc.1995-03-10
CAPNO-FLO(TM) REGULATOR (K945822)Kirk Specialty Systems1995-02-24
4-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050 (K950392)Cal West Trading Co.1995-02-21
CPR MICROMASK (K943386)Plasco, Inc.1995-02-21
CPR SHIELD (K942671)Rondex Products, Inc.1995-02-07
PPM III (K940712)O-Two Systems Intl., Inc.1994-11-14
COMPLETE CPR KIT (K941008)Mtm Health Products , Ltd.1994-11-10
NON-BREATHING VALVE (K943761)Rondex Products, Inc.1994-11-10
4-O2 JR. (CPR MOUTH BARRIER) (K945177)Eagle Health Supplies1994-11-01
PROTECTAIDE CPR PROTECTION PACK (K942469)Protectaide, Inc.1994-10-31
PROTECTAIDE CPR PROTECTION PACK NO. 22100 (K942468)Protectaide, Inc.1994-10-31
RESCUE BREATHER (K940927)O-Two Systems Intl., Inc.1994-10-14
PROTECTAIDE CPR PROTECTION PACK NO. 17701 (K942466)Protectaide, Inc.1994-10-06
PROTECTAIDE AVIATOR CPR PROTECTION PACK NO. 31000 (K942467)Protectaide, Inc.1994-10-06
K.P.R. (KING PERSONAL RESUSCITATOR) (K943402)King Systems Corp.1994-08-19
MOUTH TO MOUTH BREATHER (K942021)Gam Industries, Inc.1994-06-22
CPROTECTOR (K934821)Certified Safety Mfg., Inc.1994-01-06
MAGNASHIELD CPR MOUTH BARRIER (K933756)Cal West Trading Co.1994-01-05
NON REBREATHING VALVE (K913163)Specialty Packaging Producs, Inc.1992-02-03
RONDEX CPR NON REBREATHING VALVE #9030, MODIFIED (K914195)Rondex Products, Inc.1991-11-08
CPR VALVE (NON-REBREATHING) MODEL #9030 (K902299)Rondex Products, Inc.1990-10-26
NON-REBREATHING AIRWAY AND MASK(S) KITS (K891124)Airway Products, Inc.1989-10-13
LSP DEMAND INHALATOR VALVE MODEL SPOO68 W/MASK (K884543)Sechrist Industries, Inc.1988-12-13
LIFEGUARD VENT MASK (K883383)Breath of Life, Inc.1988-11-21
NON-REBREATHING TEE PIECE (NRTP) (K883988)Dhd Medical Products Div. Diemolding Corp.1988-10-07
RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR (K881931)Rondex Products, Inc.1988-07-21
RESUSCITATOR VALVE ASSEMBLY W/FILTER (K882204)Intertech/Ohio1988-07-08
LIFECARE EXHALATION VALVE #06-699 (K873570)Lifecare Services, Inc.1987-11-30
HY-FLOW NON-REBREATHING VALVE ASSEMBLY (K871367)Med Air Technology, Inc.1987-06-19
CARHILL ONE-WAY RESUSCITATION VALVE (K864681)Life Design Systems, Inc.1987-05-21
NO. 1552, VALVED VENTI-COMP (K870895)Hudson Oxygen Therapy Sales Co.1987-05-04
DRV DISP RESUSCIT 3000/BAG ADAPT 3010 & 3011 (K870382)Nova-Ventrx1987-03-06
INSPIRON(R) BREATH FOR LIFE EMERG. RESUSCITATOR (K870253)Intertech Resources, Inc.1987-03-06
1160 SIMPLE ISOLATION VALVE & 1161 FILTERED VALVE (K870138)Hudson Oxygen Therapy Sales Co.1987-03-06
PERSON TO PERSON VALVE-MASK & TRI-SEAL FACE MASK (K864472)Tagg Industries1987-01-12
LAERDAL POCKET MASK (K861401)Laerdal Medical Corp.1986-05-21
RONDEX CPR VALVE (K855218)Kondex Products, Inc.1986-02-12
RESCUE VALVE (K833748)Respironics, Inc.1983-12-08
RESUSCITATION VALVE (K832868)Boehringer Laboratories1983-09-26
WHISTLER IN-LINE PRESSURE RELEASE VALVE (K831246)Airlife, Inc.1983-07-26
CM 3 (K810348)Instrumentation Industries, Inc.1981-02-23
RETARD VALVE 3-STACK #M-515 (K791907)Mem Medical, Inc.1979-10-09
RETARD VALVE 3-STACK #M-514 (K791908)Mem Medical, Inc.1979-10-09
ONE-WAY VALVE-MALE, M-504 (K791849)Mem Medical, Inc.1979-10-01
ONE-WAY VALVE-FEMALE, M-503 (K791850)Mem Medical, Inc.1979-10-01
NON-REBREATHING T PIECE (K790820)Dhd Medical Products Div. Diemolding Corp.1979-05-04
ONE-WAY VALVE (K790151)Airlife, Inc.1979-03-12
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Every clearance here is in the API, with alerts when new ones post.