Atlas FDA

BTM

209 FDA 510(k) clearances · Product code

87 daysmedian time to decision
267 days90th percentile
209clearances measured

FDA profile

Official device name
Ventilator, Emergency, Manual (Resuscitator)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5915
Medical specialty
Anesthesiology
Flags
Life-sustaining · Third-party review eligible
Adverse events (MAUDE)
2021: 42 · 2022: 35 · 2023: 46 · 2024: 33 · 2025: 36 · 2026: 31
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
The BAG manual resuscitator and accessories (K251631)Laerdal Medical AS2025-11-24
butterflyBVM (K243861)Compact Medical, Inc.2025-04-25
EOlife® (K221841)Archeon2023-03-18
Sotair Device (K212905)Safe Bvm Corporation2022-08-18
Disposable Manual Resuscitator (K210288)Xiamen Compower Medical Tech. Co., Ltd.2021-08-26
Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20 (K181583)Flexicare Medical Limited.2018-12-07
Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer (K170663)Foremount Enterprise Co., Ltd.2018-05-11
Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator (K152931)Ambu A/S2016-08-29
NEONATALIE RESUSCITATOR (K132172)Laerdal Medical A/S2015-01-15
BABI PLUS NEONATAL RESUSCITATION BAG (K112852)A Plus Medical2012-01-13
AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC (K102824)Ambu A/S2011-01-28
NEOPOP INFANT RESUSCITATOR WITH FLOW METER (K102649)Neoforce Group, Inc.2011-01-06
REVIVATOR (K094003)Hersill, S.L.2010-09-17
POCKET BVM (K093081)Microbvm Systems , Ltd.2010-02-05
DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE (K082092)Galemed Corp.2008-10-15
SAVE RESUSCITATOR (K073410)Artivent Corporation2008-09-12
RESUSCITATION TIMER, MODEL L770-CPR (K073171)Allied Healthcare Products, Inc.2008-01-31
NEOPIP INFANT RESUSCITATOR (K072021)Neoforce Group, Inc.2007-09-12
GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM (K070247)Ohmeda Medical2007-04-20
RESUSCITATION TIMER, MODEL L770-CPR (K062080)Allied Healthcare Products, Inc.2006-10-18
HSINER RESUSCITATOR (K053466)Hsiner Co., Ltd.2006-03-22
AMBU MARK IV RESUSCITATOR (K053140)Ambu A/S2005-12-23
AMBU MARK IV BABY RESUSCITATOR (K053142)Ambu A/S2005-12-20
PVC AND SILICONE MANUAL RESUSCITATORS (K051177)David Medical Products Co.,Ltd2005-08-29
SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022, (K042556)Enter Medical Corporation2005-03-11
AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR (K042682)Ambu, Inc.2004-11-15
AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS (K042843)Ambu, Inc.2004-11-12
STURDY MANUAL RESUSCITATOR (K032596)Sturdy Industrial Co., Ltd.2004-08-05
MERLIN RESUSCITATOR (K031395)Merlin Medical Limited2004-07-16
BAWMED E-Z BAG RESUSCITATOR (K031434)Bawmed UK2004-02-06
VADI MANUAL RESUSCITATOR (K030864)Vedi Corp.2004-01-30
SMART BAG MO (K021328)O-Two Systems International, Inc.2003-06-26
1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR (K023793)Portex, Inc.2003-02-11
NELLCOR INDGO MANUAL RESUSCITATOR (K023494)Nellcor Puritan Bennett, Inc.2003-02-07
OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR (K021446)Oemedic International, Inc.2002-10-11
SIMPLIFY COMPACT RESUSCITATOR (K021716)Polymed (Xiamen) Plastic Industrial Co., Ltd.2002-10-08
ACUTEVENTILATOR (K012271)Impoex International, Ltd.2002-10-04
PMX COMPACT RESUCITATOR (K021390)Cheen Houng Ent. Co. , Ltd.2002-10-04
PMX DISPOSABLE BAG MASK RESUSCITATOR (K014071)Allied Healthcare Products, Inc.2002-10-01
OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & RESERVOIR (K021442)Oemedic International, Inc.2002-07-30
1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX (K014115)Portex, Inc.2002-02-27
V*CARE MANUAL RESUSCITATOR (K012842)Ventlab Corp.2001-09-18
Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02 (K003927)Cheen Houng Ent. Co. , Ltd.2001-06-26
HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR (K002846)Headstar Medical Products Co., Ltd.2001-06-06
AMBU NEONATE SILICONE RESUSCITATOR (K993278)Ambu, Inc.2000-05-17
RUSCH MANUAL RESUSCITATOR BAG (K993194)Rusch, Inc.2000-03-24
1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE (K991861)Sims Portex, Inc.2000-01-18
IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006 (K992057)Sims Portex, Inc.1999-09-13
MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION (K991955)Engineered Medical Systems1999-07-06
MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION (K991953)Engineered Medical Systems1999-07-01
MANUAL RESUSCITATOR WITH ACE (K982215)Medical Marketing Concepts1998-09-18
CPR FILTERSHIELD (K980066)Plasco, Inc.1998-07-16
INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL PULMONARY RESUSCITATOR WITH RUBBER COMPRESSION BAG (K981308)International Respiratory Systems, Inc.1998-07-06
INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR (K981307)International Respiratory Systems, Inc.1998-07-06
PLUS REUSABLE RESUSCITATOR (K974141)Schiff & Co.1998-05-21
DMR PLUS DISPOSABLE MANUAL RESUSCITATOR (K973419)Nellcor Puritan Bennett, Inc.1998-03-25
GOLEMB DISPOSABLE BAG MASK RESUSCITATOR (K973106)Allied Healthcare Products, Inc.1998-01-29
OHMEDA INFANT RESUSCITATION SYSTEM (K971243)Ohmeda Medical1997-12-02
MERCURY MEDICAL REUSABLE CPR BAG (K970756)Mercury Medical1997-10-31
SIMS 1ST RESPONSE MANUAL RESUSCITATOR, ADULT (K972283)Sims1997-09-17
ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOPE ADAPTER,IN-LINE SPECIMEN TRAP (K972139)Davis & Geck, Inc.1997-09-03
MANUAL RESUSCITATOR (K963848)Owens-Brigam Medical Co.1997-07-07
DATEX ENGSTOM MANUAL RESUSCITATOR (K970991)Promedic, Inc.1997-06-16
INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT) (K970959)Instrumentation Industries, Inc.1997-06-13
AMBU SPUR NEONATE (K964584)Ambu, Inc.1997-05-15
HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR (K964719)Hudson Respiratory Care, Inc.1997-02-21
GRAYCO POCKET PUMP (K955507)Grayco, Inc.1996-08-15
BAGRIGHT CHILD RESUSCITATOR (K961329)Medical Marketing Concepts1996-07-02
BAGRIGHT INFANT RESUSCITATOR (K961330)Medical Marketing Concepts1996-07-02
BAGRIGHT RESPOSABLE INFANT RESUSCITATOR (K961332)Medical Marketing Concepts1996-06-28
BAGRIGHT RESPOSABLE RESUSCITATOR (K961369)Medical Marketing Concepts1996-06-28
RESPOSABLE CHILD RESUSCITATOR (K961868)Medical Marketing Concepts1996-06-28
BAGRIGHT RESPOSABLE CHILD RESUSCITATOR (K961331)Medical Marketing Concepts1996-06-28
RESPOSABLE INFANT RESUSCITATOR (K961882)Medical Marketing Concepts1996-06-28
DMR/CO2 COMBO KTI (K960468)Nellcor Puritan Bennett, Inc.1996-04-26
MANUAL PULMONARY RESUSICITATOR (K953546)Medical Marketing Concepts1996-02-29
MERCURY CPR (COMPLETE PERSONAL RESUSCIATOR) BAG WITH EXPANDABLE RESERVOIR (K954866)Mercury Medical1996-01-30
VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) (K954150)Green Field Medical Sourcing, Inc.1995-12-20
BAGRIGHT RESUSCITATOR (K954296)Medical Marketing Concepts1995-12-20
RESPOSABLE RESUSCITATOR (K953617)Medical Marketing Concepts1995-11-22
LIFEMASK FACE SHIELD (K953824)Carefree Trading, Inc.1995-09-19
CAPNO-FLO REGULATOR, CAPNO-FLO (K952512)Kirk Specialty Systems1995-08-28
SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC (K952169)Intertech Resources, Inc.1995-06-08
RESPIRONICS BAGEASY ENCOR ADULT SEMI-REUSABLE (K934699)Respironics, Inc.1995-01-05
HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR CATALOG NUMBERS: 5360 THROUGH 5380 (K944301)Hudson Respiratory Care, Inc.1994-12-21
PURITAN-BENNETT DISPOSABLE MANUAL RESUSCITATOR (DMR) (K944347)Puritan Bennett Corp.1994-12-12
MATRX HOPE(R) 5 RESUSCITATOR (K921982)Matrix Medica, Inc.1994-10-28
BNOS MICRO VENT, MODEL AC AND MODEL AO (K941037)Reeves Manufactoring1994-08-18
DISPOSABLE MANUAL RESUSCITATOR (K943617)Puritan-Bennett1994-08-11
BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS (K940581)Respironics, Inc.1994-05-06
BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR (K934310)Respironics, Inc.1993-12-14
LSP (MODEL 554) BAG MASK RESUSCITATOR (K922691)Life Support Products, Inc.1993-11-24
INFANT DISPOSABLE BAG MASK RESUSCITATOR (K922819)Life Support Products, Inc.1993-11-24
CAPNO-FLO (K933626)Kirk Specialty Systems1993-10-06
PRESSURE LIMITING ELBOW (K932797)Engineered Medical Systems1993-09-03
BAXTER ADULT/PEDI INFANT SINGLE/USE MAN RESUSCIT (K924671)Engineered Medical Systems1993-04-21
BAXTER ADULT/PEDI/INFANT SINGLE USE MAN RESUSCIT (K924610)Engineered Medical Systems1993-04-06
AID, CARDIOPULMONARY RESUSCITATION (K930429)Valley Forge Scientific Corp.1993-03-11
SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE (K923762)Ambu, Inc.1993-02-05
RESPIRE DISPOSABLE PULMONARY RESUSCITATOR (K913474)Med-Tek Innovations, Inc.1993-02-03
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