Ventilator, Emergency, Manual (Resuscitator)
FDA product code BTM · Class II (moderate risk) · 21 CFR 868.5915 · Anesthesiology
209510(k) clearances
0PMA approvals
82recalls
Manufacturers
- Ambu, Inc. 15
- Puritan Bennett Corp. 13
- Medical Marketing Concepts 11
- Life Design Systems, Inc. 7
- Engineered Medical Systems 6
- Life Support Products, Inc. 6
- Vital Signs, Inc. 6
- Respironics, Inc. 5
- Ambu A/S 4
- Intertech Resources, Inc. 4
- Allied Healthcare Products, Inc. 4
- Rondex Products, Inc. 3
- O-Two Systems Intl., Inc. 3
- Nellcor Puritan Bennett, Inc. 3
- Instrumentation Industries, Inc. 3
- Laerdal Medical Corp. 3
- Ventlab Corp. 2
- Lifeguard Medical Products, Inc. 2
- Merced Medical, Inc. 2
- Hudson Oxygen Therapy Sales Co. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251631 | The BAG manual resuscitator and accessoriesBTM · Traditional | Laerdal Medical AS | 11/24/2025SE |
| K243861 | butterflyBVMBTM · Traditional | Compact Medical, Inc. | 04/25/2025SE |
| K221841 | EOlife®BTM · Traditional | Archeon | 03/18/2023SE |
| K212905 | Sotair DeviceBTM · Traditional | Safe Bvm Corporation | 08/18/2022SE |
| K210288 | Disposable Manual ResuscitatorBTM · Traditional | Xiamen Compower Medical Tech. Co., Ltd. | 08/26/2021SE |
| K181583 | Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator…BTM · Traditional | Flexicare Medical Limited. | 12/07/2018SE |
| K170663 | Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount…BTM · Traditional | Foremount Enterprise Co., Ltd. | 05/11/2018SE |
| K152931 | Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II…BTM · Abbreviated | Ambu A/S | 08/29/2016SE |
| K132172 | Neonatalie ResuscitatorBTM · Abbreviated | Laerdal Medical A/S | 01/15/2015SE |
| K112852 | Babi Plus Neonatal Resuscitation BagBTM · Traditional | A Plus Medical | 01/13/2012SE |
| K102824 | Ambu Oval Silicone Resuscitator, Adult and PediatricBTM · Abbreviated | Ambu A/S | 01/28/2011SE |
| K102649 | Neopop Infant Resuscitator with Flow MeterBTM · Traditional | Neoforce Group, Inc. | 01/06/2011SE |
| K094003 | RevivatorBTM · Abbreviated | Hersill, S.L. | 09/17/2010SE |
| K093081 | Pocket BVMBTM · Traditional | Microbvm Systems , Ltd. | 02/05/2010SE |
| K082092 | Dispo-Bag Manual Resuscitator, Disposable Adjustable Peep Valve, Disposable Fixed Peep…BTM · Traditional | Galemed Corp. | 10/15/2008SE |
| K073410 | Save ResuscitatorBTM · Traditional | Artivent Corporation | 09/12/2008SE |
| K073171 | Resuscitation Timer, Model L770-CPRBTM · Traditional | Allied Healthcare Products, Inc. | 01/31/2008SE |
| K072021 | Neopip Infant ResuscitatorBTM · Traditional | Neoforce Group, Inc. | 09/12/2007SE |
| K070247 | Giraffe and Panda Bag and Mask Resuscitation SystemBTM · Traditional | Ohmeda Medical | 04/20/2007SE |
| K062080 | Resuscitation Timer, Model L770-CPRBTM · Traditional | Allied Healthcare Products, Inc. | 10/18/2006SE |
| K053466 | Hsiner ResuscitatorBTM · Abbreviated | Hsiner Co., Ltd. | 03/22/2006SE |
| K053140 | Ambu Mark IV ResuscitatorBTM · Traditional | Ambu A/S | 12/23/2005SE |
| K053142 | Ambu Mark IV Baby ResuscitatorBTM · Traditional | Ambu A/S | 12/20/2005SE |
| K051177 | PVC and Silicone Manual ResuscitatorsBTM · Traditional | David Medical Products Co.,Ltd | 08/29/2005SE |
| K042556 | Shineball PVC Manual Resusciator, ENT-1001, ENT-1003, ENT-1005, Shineball Silicone…BTM · Traditional | Enter Medical Corporation | 03/11/2005SE |
| K042682 | Ambu Spur Ii. Adult Single Patient ResuscitatorBTM · Traditional | Ambu, Inc. | 11/15/2004SE |
| K042843 | Ambu Spur II Infant and Pediatric Single Patient Use ResuscitatorsBTM · Traditional | Ambu, Inc. | 11/12/2004SE |
| K032596 | Sturdy Manual ResuscitatorBTM · Traditional | Sturdy Industrial Co., Ltd. | 08/05/2004SE |
| K031395 | Merlin ResuscitatorBTM · Traditional | Merlin Medical Limited | 07/16/2004SE |
| K031434 | Bawmed E-Z Bag ResuscitatorBTM · Traditional | Bawmed UK | 02/06/2004SE |
| K030864 | Vadi Manual ResuscitatorBTM · Traditional | Vedi Corp. | 01/30/2004SE |
| K021328 | Smart Bag MoBTM · Traditional | O-Two Systems International, Inc. | 06/26/2003SE |
| K023793 | 1ST Response Intermediate Manual ResuscitatorBTM · Traditional | Portex, Inc. | 02/11/2003SE |
| K023494 | Nellcor Indgo Manual ResuscitatorBTM · Special | Nellcor Puritan Bennett, Inc. | 02/07/2003SE |
| K021446 | Oemedic International Inc. Besmed Silicone Adult, Child, Infant Manual Resuscitator with…BTM · Traditional | Oemedic International, Inc. | 10/11/2002SE |
| K021716 | Simplify Compact ResuscitatorBTM · Traditional | Polymed (Xiamen) Plastic Industrial Co., Ltd. | 10/08/2002SE |
| K021390 | PMX Compact ResucitatorBTM · Traditional | Cheen Houng Ent. Co. , Ltd. | 10/04/2002SE |
| K012271 | AcuteventilatorBTM · Traditional | Impoex International, Ltd. | 10/04/2002SE |
| K014071 | PMX Disposable Bag Mask ResuscitatorBTM · Traditional | Allied Healthcare Products, Inc. | 10/01/2002SE |
| K021442 | Oemedic International Inc. Besmed Single Use Adult, Child, Infant Manual Resuscitator…BTM · Traditional | Oemedic International, Inc. | 07/30/2002SE |
| K014115 | 1ST Response Manual Resuscitator, Model 85XXBTM · Traditional | Portex, Inc. | 02/27/2002SE |
| K012842 | V*Care Manual ResuscitatorBTM · Special | Ventlab Corp. | 09/18/2001SE |
| K003927 | Y2000 Manual Resuscitator, Model RUGU01/RUG02 and RUGH01/RUGH02BTM · Traditional | Cheen Houng Ent. Co. , Ltd. | 06/26/2001SE |
| K002846 | Headstar's Manual Emergency ResuscitatorBTM · Traditional | Headstar Medical Products Co., Ltd. | 06/06/2001SE |
| K993278 | Ambu Neonate Silicone ResuscitatorBTM · Traditional | Ambu, Inc. | 05/17/2000SE |
| K993194 | Rusch Manual Resuscitator BagBTM · Traditional | Rusch, Inc. | 03/24/2000SE |
| K991861 | 1ST Response Infant Manual Resuscitator, Bag Resevoir, 1ST Response Pediatric Manual…BTM · Traditional | Sims Portex, Inc. | 01/18/2000SE |
| K992057 | Ist Response Manual Resuscitator, Models, 008000, 008003,008006BTM · Traditional | Sims Portex, Inc. | 09/13/1999SE |
| K991955 | Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2…BTM · Traditional | Engineered Medical Systems | 07/06/1999SE |
| K991953 | Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2…BTM · Traditional | Engineered Medical Systems | 07/01/1999SE |
| K982215 | Manual Resuscitator with AceBTM · Traditional | Medical Marketing Concepts | 09/18/1998SE |
| K980066 | CPR FiltershieldBTM · Traditional | Plasco, Inc. | 07/16/1998SE |
| K981308 | International Respiratory Systems, Inc.'s Manual Pulmonary Resuscitator with Rubber…BTM · Traditional | International Respiratory Systems, Inc. | 07/06/1998SE |
| K981307 | International Respiratory Systems, Inc.'s Manual ResusciatorBTM · Traditional | International Respiratory Systems, Inc. | 07/06/1998SE |
| K974141 | Plus Reusable ResuscitatorBTM · Traditional | Schiff & Co. | 05/21/1998SE |
| K973419 | DMR Plus Disposable Manual ResuscitatorBTM · Traditional | Nellcor Puritan Bennett, Inc. | 03/25/1998SE |
| K973106 | Golemb Disposable Bag Mask ResuscitatorBTM · Traditional | Allied Healthcare Products, Inc. | 01/29/1998SE |
| K971243 | Ohmeda Infant Resuscitation SystemBTM · Traditional | Ohmeda Medical | 12/02/1997SE |
| K970756 | Mercury Medical Reusable CPR BagBTM · Traditional | Mercury Medical | 10/31/1997SE |
| K972283 | Sims 1ST Response Manual Resuscitator, AdultBTM · Traditional | Sims | 09/17/1997SE |
| K972139 | Aspr-Care Closed System,Dual Swivel Piece T,Sheathed Suction Catheter,Bronchosope…BTM · Traditional | Davis & Geck, Inc. | 09/03/1997SE |
| K963848 | Manual ResuscitatorBTM · Traditional | Owens-Brigam Medical Co. | 07/07/1997SE |
| K970991 | Datex Engstom Manual ResuscitatorBTM · Traditional | Promedic, Inc. | 06/16/1997SESK |
| K970959 | Instant Flow Vavle (Flowmeter, Pole, Rail, Wall Mount)BTM · Traditional | Instrumentation Industries, Inc. | 06/13/1997SE |
| K964584 | Ambu Spur NeonateBTM · Traditional | Ambu, Inc. | 05/15/1997SE |
| K964719 | Hudson Rci Lifesaver Single Patient Use Manual ResuscitatorBTM · Traditional | Hudson Respiratory Care, Inc. | 02/21/1997SE |
| K955507 | Grayco Pocket PumpBTM · Traditional | Grayco, Inc. | 08/15/1996SE |
| K961330 | Bagright Infant ResuscitatorBTM · Traditional | Medical Marketing Concepts | 07/02/1996SE |
| K961329 | Bagright Child ResuscitatorBTM · Traditional | Medical Marketing Concepts | 07/02/1996SE |
| K961882 | Resposable Infant ResuscitatorBTM · Traditional | Medical Marketing Concepts | 06/28/1996SE |
| K961868 | Resposable Child ResuscitatorBTM · Traditional | Medical Marketing Concepts | 06/28/1996SE |
| K961369 | Bagright Resposable ResuscitatorBTM · Traditional | Medical Marketing Concepts | 06/28/1996SE |
| K961332 | Bagright Resposable Infant ResuscitatorBTM · Traditional | Medical Marketing Concepts | 06/28/1996SE |
| K961331 | Bagright Resposable Child ResuscitatorBTM · Traditional | Medical Marketing Concepts | 06/28/1996SE |
| K960468 | DMR/CO2 Combo KtiBTM · Traditional | Nellcor Puritan Bennett, Inc. | 04/26/1996SESK |
| K953546 | Manual Pulmonary ResusicitatorBTM · Traditional | Medical Marketing Concepts | 02/29/1996SE |
| K954866 | Mercury CPR (Complete Personal Resusciator) Bag with Expandable ReservoirBTM · Traditional | Mercury Medical | 01/30/1996SE |
| K954296 | Bagright ResuscitatorBTM · Traditional | Medical Marketing Concepts | 12/20/1995SE |
| K954150 | Ventilator, Emergency, Manual (Resuscitator)BTM · Traditional | Green Field Medical Sourcing, Inc. | 12/20/1995SE |
| K953617 | Resposable ResuscitatorBTM · Traditional | Medical Marketing Concepts | 11/22/1995SE |
| K953824 | Lifemask Face ShieldBTM · Traditional | Carefree Trading, Inc. | 09/19/1995SE |
| K952512 | Capno-Flo Regulator, Capno-FloBTM · Traditional | Kirk Specialty Systems | 08/28/1995SE |
| K952169 | Safe Response Mouth-To-Mask Resuscitator, PediatricBTM · Traditional | Intertech Resources, Inc. | 06/08/1995SE |
| K934699 | Respironics Bageasy Encor Adult Semi-ReusableBTM · Traditional | Respironics, Inc. | 01/05/1995SE |
| K944301 | Hudson Rci Lifesaver Single Patient Use Manual Resuscitator Catalog Numbers: 5360…BTM · Traditional | Hudson Respiratory Care, Inc. | 12/21/1994SE |
| K944347 | Puritan-Bennett Disposable Manual Resuscitator (DMR)BTM · Traditional | Puritan Bennett Corp. | 12/12/1994SE |
| K921982 | Matrx Hope(R) 5 ResuscitatorBTM · Traditional | Matrix Medica, Inc. | 10/28/1994SE |
| K941037 | Bnos Micro Vent, Model Ac and Model AoBTM · Traditional | Reeves Manufactoring | 08/18/1994SE |
| K943617 | Disposable Manual ResuscitatorBTM · Traditional | Puritan-Bennett | 08/11/1994SE |
| K940581 | Bageasy(R) III Child/Infant Dispos Man ResuscitatorsBTM · Traditional | Respironics, Inc. | 05/06/1994SE |
| K934310 | Bageasy(R) III Adult Disposable Manual ResuscitatorBTM · Traditional | Respironics, Inc. | 12/14/1993SE |
| K922819 | Infant Disposable Bag Mask ResuscitatorBTM · Traditional | Life Support Products, Inc. | 11/24/1993SE |
| K922691 | LSP (Model 554) Bag Mask ResuscitatorBTM · Traditional | Life Support Products, Inc. | 11/24/1993SE |
| K933626 | Capno-FloBTM · Traditional | Kirk Specialty Systems | 10/06/1993SE |
| K932797 | Pressure Limiting ElbowBTM · Traditional | Engineered Medical Systems | 09/03/1993SE |
| K924671 | Baxter Adult/Pedi Infant Single/Use Man ResuscitBTM · Traditional | Engineered Medical Systems | 04/21/1993SE |
| K924610 | Baxter Adult/Pedi/Infant Single Use Man ResuscitBTM · Traditional | Engineered Medical Systems | 04/06/1993SE |
| K930429 | Aid, Cardiopulmonary ResuscitationBTM · Traditional | Valley Forge Scientific Corp. | 03/11/1993SE |
| K923762 | Spur Infant/Child W/O Pressure-Limiting ValveBTM · Traditional | Ambu, Inc. | 02/05/1993SE |
| K913474 | Respire Disposable Pulmonary ResuscitatorBTM · Traditional | Med-Tek Innovations, Inc. | 02/03/1993SE |
| K922810 | OdysseyBTM · Traditional | O-Two Systems Intl., Inc. | 01/22/1993SE |
| K913714 | Modification Manual Pulmon Resuscitor/Pulmanex(Tm)BTM · Traditional | Life Design Systems, Inc. | 12/01/1992SE |
| K921553 | Lspi Infant Bag MaskBTM · Traditional | Life Support Products, Inc. | 10/19/1992SE |
| K921002 | Rondex Mask Models 9122/9111/9102/911102, ModifiedBTM · Traditional | Rondex Products, Inc. | 10/06/1992SE |
| K924217 | Lspi Disposable Bag Mask Resuscitator/ModifiedBTM · Traditional | Life Support Products, Inc. | 09/17/1992SE |
| K924216 | Ambu Silicone Resuscitator Infan/Child W/Open ResoBTM · Traditional | Ambu, Inc. | 09/16/1992SE |
| K924215 | Ambu Silicone Resuscitator, Adult W/Open ReservoirBTM · Traditional | Ambu, Inc. | 09/16/1992SE |
| K922712 | Spur Infant/Child with Open Reservoir SystemBTM · Traditional | Ambu, Inc. | 06/19/1992SE |
| K922707 | Spur Adult with Open Reservoir SystemBTM · Traditional | Ambu, Inc. | 06/19/1992SE |
| K922004 | Modification Puritan-Bennett Infant PM2BTM · Traditional | Puritan Bennett Corp. | 05/28/1992SE |
| K915810 | Mer BagBTM · Traditional | Merced Medical, Inc. | 03/09/1992SE |
| K920570 | Puritan-Bennet Infant Manual Resuscitator ModifiedBTM · Traditional | Puritan Bennett Corp. | 02/27/1992SE |
| K913900 | V*Care Manual Resuscitator, CAT#VR-1000BTM · Traditional | Ventlab Corp. | 01/07/1992SE |
| K912620 | Opomat Manual Resuscitator VentilatorBTM · Traditional | Euro-Am Pharma, Inc. | 12/04/1991SE |
| K912203 | EMS Single Use Manual ResuscitatorsBTM · Traditional | Engineered Medical Systems | 11/13/1991SE |
| K914196 | Rondex Masks Models 9015/9011/901102 ModifiedBTM · Traditional | Rondex Products, Inc. | 11/08/1991SE |
| K914187 | Ambu Silicone Resuscitator Infant/ChildBTM · Traditional | Ambu, Inc. | 10/07/1991SE |
| K913370 | Modification Manual Resuscitator (PMR 2)BTM · Traditional | Puritan Bennett Corp. | 08/26/1991SE |
| K911971 | Modified Single Patient Use Disp. Manual Resuscit.BTM · Traditional | Puritan Bennett Corp. | 08/09/1991SE |
| K912625 | Mouth to Mask ResuscitatorBTM · Traditional | Vital Signs, Inc. | 08/02/1991SE |
| K904899 | Vital Signs Code Blue Adult Manual ResuscitatorBTM · Traditional | Vital Signs, Inc. | 07/24/1991SE |
| K911298 | Pressure Limiting Elbow with Manometer PortBTM · Traditional | Intertech Resources, Inc. | 06/25/1991SE |
| K910856 | Manual ResuscitatorBTM · Traditional | Vital Signs, Inc. | 06/18/1991SE |
| K910040 | Ambu Sir 2 (Silicone Resuscitator), AdultBTM · Traditional | Ambu, Inc. | 05/28/1991SE |
| K911622 | CPR BagBTM · Traditional | Merced Medical, Inc. | 05/20/1991SE |
| K905304 | Dresser Argus P/N 1818BTM · Traditional | Dresser Argus, Inc. | 04/17/1991SE |
| K905002 | Single Use Manual ResuscitatorsBTM · Traditional | Custom Medical, Inc. | 03/29/1991SE |
| K904346 | Bauman Cpr/ResuscitatorBTM · Traditional | General Medical Products, Inc. | 10/02/1990SE |
| K902733 | 1ST Response (TM) Infant Manual ResuscitatorBTM · Traditional | Intertech Resources, Inc. | 08/22/1990SE |
| K903631 | Infant Manual Resuscitator (PMR 2)BTM · Traditional | Puritan Bennett Corp. | 08/17/1990SE |
| K903570 | Single Patient Use Infant Disposable Manual ResuscBTM · Traditional | Puritan Bennett Corp. | 08/17/1990SE |
| K903443 | Modified Single Patient Use Disp Man ResuscitatorBTM · Traditional | Puritan Bennett Corp. | 08/17/1990SE |
| K903438 | Mod Puritan Bennett Sing Patient Dispos Man ResusBTM · Traditional | Puritan Bennett Corp. | 08/17/1990SE |
| K902261 | Ambu Spur (Single Patient Use Resuscitator) InfantBTM · Traditional | Ambu, Inc. | 07/16/1990SE |
| K900577 | 1ST Response Reusable Manual Resuscitator (Adult)BTM · Traditional | Intertech Resources, Inc. | 07/16/1990SE |
| K900260 | Ambu Life Key and Ambu Res-Cue KeyBTM · Traditional | Ambu, Inc. | 06/08/1990SE |
| K901218 | Life Aid ResuscitatorBTM · Traditional | Clarendon Supplies , Ltd. | 05/18/1990SE |
| K900349 | Puritan Bennett Single Patient Use Peep AdapterBTM · Traditional | Puritan Bennett Corp. | 05/01/1990SE |
| K895820 | Resuso MaskBTM · Traditional | Rml Ent., Inc. | 04/04/1990SE |
| K895589 | Manual ResuscitatorBTM · Traditional | Hudson Oxygen Therapy Sales Co. | 03/30/1990SE |
| K896886 | Artec Respond Pulmonary ResuscitatorBTM · Traditional | Artec Environmental Monitoring Division | 02/06/1990SE |
| K895351 | Respironics Infant BageasyBTM · Traditional | Respironics, Inc. | 10/27/1989SE |
| K895169 | Manual Disposable Pulmonary ResuscitatorBTM · Traditional | F.L.W. Plastics, Inc. | 10/13/1989SE |
| K894365 | Single Patient Use Disposable Manual ResuscitatorBTM · Traditional | Puritan Bennett Corp. | 10/06/1989SE |
| K885243 | NEOVO2R VentilatoryBTM · Traditional | Neomed | 07/24/1989SE |
| K892221 | Pulmonary Resuscitator, ModificationBTM · Traditional | Life Design Systems, Inc. | 05/18/1989SE |
| K881881 | Oxygenation CatheterBTM · Traditional | Ventech Healthcare Corp., Inc. | 02/17/1989SE |
| K881483 | Airway-Circulation EvaluatorBTM · Traditional | Resuscitation Ace, Inc. | 12/16/1988SE |
| K884526 | Adult Resuscitator with Mask and FilterBTM · Traditional | Intertech/Ohio | 11/16/1988SE |
| K884068 | Pulmanex TM (Neo-Natal Size)BTM · Traditional | Life Design Systems, Inc. | 11/16/1988SE |
| K883434 | Ambu Spur (Single Patient Use Resuscitator)BTM · Traditional | Ambu, Inc. | 09/14/1988SE |
| K882285 | Nonrebreathing CircuitBTM · Traditional | Dryden Corp. | 08/16/1988SE |
| K881207 | Res-Q 1, 2, 3, 4 and 5BTM · Traditional | Nova-Ventrx | 08/15/1988SE |
| K881686 | CPR BagBTM · Traditional | Devolve Corp. | 06/23/1988SE |
| K882278 | Resuscitation Bag Controller (RBC)BTM · Traditional | Physician Engineered Products, Inc. | 06/16/1988SE |
| K881087 | Lifeguard Single Use Manual ResuscitatorsBTM · Traditional | Lifeguard Medical Products, Inc. | 04/14/1988SE |
| K881086 | Lifeguard Mouth to Mask ResuscitatorBTM · Traditional | Lifeguard Medical Products, Inc. | 04/14/1988SE |
| K880450 | Resusci Patient Face ShieldBTM · Traditional | Laerdal Medical Corp. | 03/04/1988SE |
| K880394 | First Response Pediatric Emergency ResuscitatorBTM · Traditional | Intertech/Ohio | 02/29/1988SE |
| K874567 | ResuscitatorBTM · Traditional | American Medical Technology, Inc. | 02/29/1988SE |
| K874418 | LSP Disposable Bag Resuscitator, Model 470BTM · Traditional | Life Support Products, Inc. | 01/22/1988SE |
| K875077 | Herco Silicone Resuscitator or Sun-Med Resuscita.BTM · Traditional | Herco Products, Inc. | 01/19/1988SE |
| K874321 | Solco Silicone ResuscitatorBTM · Traditional | Kahn-Tact U.S.A., Inc. | 01/19/1988SE |
| K873286 | Disposable, Manual Pulmonary ResuscitatorBTM · Traditional | Hospitak, Inc. | 10/26/1987SE |
| K873043 | Mouth to Face ResuscitatorBTM · Traditional | Artec Environmental Monitoring Division | 09/28/1987SE |
| K871147 | Modified CpreviverBTM · Traditional | Augerscope, Inc. | 04/20/1987SE |
| K864308 | Bauman Cpr/RespiratorBTM · Traditional | General Medical Products, Inc. | 03/09/1987SE |
| K864125 | CpreviverBTM · Traditional | Augerscope, Inc. | 02/26/1987SE |
| K863026 | Pulmanex TM (Modification)BTM · Traditional | Life Design Systems, Inc. | 08/26/1986SE |
| K860693 | Pulmanex (TM)BTM · Traditional | Life Design Systems, Inc. | 03/27/1986SE |
| K860180 | Model 446 & 447 Mouth to Mask ResuscitatorBTM · Traditional | Life Support Products, Inc. | 03/06/1986SE |
| K854037 | PulmanexBTM · Traditional | Life Design Systems, Inc. | 11/01/1985SE |
| K851171 | Combibag Manual ResuscitatorBTM · Traditional | Frontline Medical Corp. | 09/06/1985SE |
| K852096 | Resus-Aid Disposable Resuscitation ShieldBTM · Traditional | Emergency Situation Products | 07/08/1985SE |
| K844729 | Resuscitator, Pulmonary, ManualBTM · Traditional | Life Design Systems, Inc. | 03/25/1985SE |
| K850436 | Stat Blue Dispos. Manual ResuscitatorBTM · Traditional | Vital Signs, Inc. | 02/26/1985SE |
| K844420 | Med-Life Emergency Oxygen Regreather/ResuscitatorBTM · Traditional | Med-Life, Inc. | 12/17/1984SE |
| K843223 | Flow ControllerBTM · Traditional | Precision Medical, Inc. | 09/27/1984SE |
| K842693 | Respironics VenteasyBTM · Traditional | Respironics, Inc. | 08/10/1984SE |
| K842696 | Life-Mask Infant ResuscitatorBTM · Traditional | Electronic Monitors, Inc. | 07/27/1984SE |
| K842487 | Samson's Newborn Lung Inflator 340-1000BTM · Traditional | J. H. Emerson Co. | 07/06/1984SE |
| K841496 | Fraser Harlake Hope III ResuscitatorBTM · Traditional | Fraser Harlake, Inc. | 04/24/1984SE |
| K840935 | Manual Resuscitation SystemBTM · Traditional | Inspiron Corp. | 04/05/1984SE |
| K840349 | Mark III ResuscitatorBTM · Traditional | Ambu, Inc. | 02/10/1984SE |
| K834250 | Rescue MaskBTM · Traditional | Rondex Products, Inc. | 01/18/1984SE |
| K834400 | Flynn Iii-Child Bag-Mask Unit EtcBTM · Traditional | O-Two Systems Intl., Inc. | 01/13/1984SE |
| K833244 | ReviveBTM · Traditional | Aladdin Industries, Inc. | 11/29/1983SE |
| K832495 | Flynn Series III Bag/Mask Unit-BTM · Traditional | O-Two Systems Intl., Inc. | 09/29/1983SE |
| K831885 | Code Blue Manual ResuscitatorBTM · Traditional | Vital Signs, Inc. | 09/08/1983SE |
| K831486 | SC-603 Twin ValveBTM · Traditional | Instrumentation Industries, Inc. | 08/12/1983SE |
| K831198 | CPR Heartsaver and BreatholatorBTM · Traditional | Cervco Corp. | 06/24/1983SE |
| K823710 | Disposable Airway AdejunctBTM · Traditional | Groves Medical Supply, Inc. | 01/21/1983SE |
| K823408 | BE#1000-INSTANT On/Off O2 ValveBTM · Traditional | Instrumentation Industries, Inc. | 12/07/1982SE |
| K822213 | Siemens-Elema AB Aga RevivatorBTM · Traditional | Siemens Elema AB | 10/28/1982SE |
| K822356 | Modulaide Emerg. Cardiac Life Supp. KTBTM · Traditional | Laerdal Medical Corp. | 08/20/1982SE |
| K820059 | Resuscitation MaskBTM · Traditional | Cederroth, Inc. USA | 03/26/1982SE |
| K812273 | Resuscitation CircuitBTM · Traditional | Vital Signs, Inc. | 08/25/1981SE |
| K812022 | Zee Manual ResuscitatorBTM · Traditional | Zee Medical Products Co., Inc. | 07/31/1981SE |
| K803066 | Disposable Bag Mask AdejunctBTM · Traditional | T. S. Enterprises, Inc. | 02/12/1981SE |
| K802813 | PMR-2 Puritan Manual ResuscitatorBTM · Traditional | Puritan Bennett Corp. | 12/17/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2357-2026 Class I | Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator…Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver… | Datex-Ohmeda Inc | 05/08/2026Open, Classified |
| Z-2181-2025 Class I | Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog…Potential for the manometer port being blocked rendering the manometer non-functional. | Ambu Inc. | 07/09/2025Open, Classified |
| Z-1814-2025 Class I | Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7…Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead… | SunMed Holdings, LLC | 05/01/2025Open, Classified |
| Z-1065-2024 Class I | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF…Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling… | Vyaire Medical | 01/10/2024Open, Classified |
| Z-1064-2024 Class I | AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask…Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling… | Vyaire Medical | 01/10/2024Open, Classified |
| Z-1063-2024 Class I | AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2…Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling… | Vyaire Medical | 01/10/2024Open, Classified |
| Z-1062-2024 Class I | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask…Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling… | Vyaire Medical | 01/10/2024Open, Classified |
| Z-1061-2024 Class I | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF…Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling… | Vyaire Medical | 01/10/2024Open, Classified |
| Z-1060-2024 Class I | AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF…Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling… | Vyaire Medical | 01/10/2024Open, Classified |
| Z-1059-2024 Class I | AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004FRisk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling… | Vyaire Medical | 01/10/2024Open, Classified |
| Z-1058-2024 Class I | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF…Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling… | Vyaire Medical | 01/10/2024Open, Classified |
| Z-1057-2024 Class I | AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000,Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling… | Vyaire Medical | 01/10/2024Open, Classified |
| Z-0369-2024 Class II | Medline manual resuscitators with integrated manometer, multiple accessory…A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | SunMed Holdings, LLC | 10/11/2023Open, Classified |
| Z-0368-2024 Class II | Curaplex manual resuscitators with integrated manometer, multiple accessory…A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | SunMed Holdings, LLC | 10/11/2023Open, Classified |
| Z-0367-2024 Class II | Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory…A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | SunMed Holdings, LLC | 10/11/2023Open, Classified |
| Z-0366-2024 Class II | Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple…A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | SunMed Holdings, LLC | 10/11/2023Open, Classified |
| Z-0365-2024 Class II | Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory…A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | SunMed Holdings, LLC | 10/11/2023Open, Classified |
| Z-0364-2024 Class II | Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory…A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | SunMed Holdings, LLC | 10/11/2023Open, Classified |
| Z-0363-2024 Class II | Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory…A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | SunMed Holdings, LLC | 10/11/2023Open, Classified |
| Z-0362-2024 Class II | Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple…A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | SunMed Holdings, LLC | 10/11/2023Open, Classified |
| Z-0361-2024 Class II | Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple…A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | SunMed Holdings, LLC | 10/11/2023Open, Classified |
| Z-2158-2018 Class II | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, PEEP VALVE AND…There is a potential for the patient port retaining ring to not fully seat allowing the patient port to… | Sun Med, LLC | 05/24/2018Terminated |
| Z-2157-2018 Class II | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER, PEEP…There is a potential for the patient port retaining ring to not fully seat allowing the patient port to… | Sun Med, LLC | 05/24/2018Terminated |
| Z-2156-2018 Class II | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER, PEEP…There is a potential for the patient port retaining ring to not fully seat allowing the patient port to… | Sun Med, LLC | 05/24/2018Terminated |
| Z-2155-2018 Class II | MEDLINE ADULT MANUAL RESUSCITATOR WITH LARGE ADULT MASK, TUBE RESERVOIR, FILTER AND 7…There is a potential for the patient port retaining ring to not fully seat allowing the patient port to… | Sun Med, LLC | 05/24/2018Terminated |
| Z-2154-2018 Class II | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER AND 7…There is a potential for the patient port retaining ring to not fully seat allowing the patient port to… | Sun Med, LLC | 05/24/2018Terminated |
| Z-2153-2018 Class II | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, CO2 AND 7 FT.…There is a potential for the patient port retaining ring to not fully seat allowing the patient port to… | Sun Med, LLC | 05/24/2018Terminated |
| Z-2152-2018 Class II | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR AND 7 FT.…There is a potential for the patient port retaining ring to not fully seat allowing the patient port to… | Sun Med, LLC | 05/24/2018Terminated |
| Z-2151-2018 Class II | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK 5, BAG RESERVOIR, PEEP VALVE…There is a potential for the patient port retaining ring to not fully seat allowing the patient port to… | Sun Med, LLC | 05/24/2018Terminated |
| Z-2150-2018 Class II | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP VALVE, CO2…There is a potential for the patient port retaining ring to not fully seat allowing the patient port to… | Sun Med, LLC | 05/24/2018Terminated |
| Z-2149-2018 Class II | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP VALVE AND…There is a potential for the patient port retaining ring to not fully seat allowing the patient port to… | Sun Med, LLC | 05/24/2018Terminated |
| Z-2148-2018 Class II | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER, CO2 AND…There is a potential for the patient port retaining ring to not fully seat allowing the patient port to… | Sun Med, LLC | 05/24/2018Terminated |
| Z-2147-2018 Class II | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER AND 7…There is a potential for the patient port retaining ring to not fully seat allowing the patient port to… | Sun Med, LLC | 05/24/2018Terminated |
| Z-2146-2018 Class II | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR AND 7 FT. OXYGEN…There is a potential for the patient port retaining ring to not fully seat allowing the patient port to… | Sun Med, LLC | 05/24/2018Terminated |
| Z-2145-2018 Class II | STAT-Check MANUAL RESUSCITATOR / VENTILATOR, REF SC9200MBP-1There is a potential for the patient port retaining ring to not fully seat allowing the patient port to… | Sun Med, LLC | 05/24/2018Terminated |
| Z-2553-2018 Class I | AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with…An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of… | Vyaire Medical | 05/08/2018Terminated |
| Z-2552-2018 Class I | AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask…An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of… | Vyaire Medical | 05/08/2018Terminated |
| Z-1809-2015 Class I | Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver…The intake port may be blocked which can cause the bag to fail to fill. | Teleflex Medical | 05/14/2015Terminated |
| Z-1948-2014 Class I | Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000…The pop-off valve in the defective devices remain open and a squeeze of the bag may not generate enough… | Ventlab LLC | 05/16/2014Terminated |
| Z-0915-2014 Class II | Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612…Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to… | GE Healthcare | 12/12/2013Terminated |
| Z-0914-2014 Class II | Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled in part…Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to… | GE Healthcare | 12/12/2013Terminated |
| Z-1071-2014 Class I | GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone…Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during… | GE Healthcare, LLC | 10/01/2013Terminated |
| Z-1947-2013 Class II | 1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual…CareFusion has received four (4) customer reports of a component (oxygen connector) within the resuscitation… | Carefusion 2200 Inc | 04/22/2013Terminated |
| Z-0749-2013 Class I | Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System…Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during… | GE Healthcare, LLC | 10/15/2012Terminated |
| Z-0181-2013 Class I | AirFlow, Small Adult Resuscitator, AF5000 Series, Single use, Manufactured by: Ventlab…Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | Ventlab Corporation | 07/11/2012Terminated |
| Z-0180-2013 Class I | AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab…Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | Ventlab Corporation | 07/11/2012Terminated |
| Z-0179-2013 Class I | Ventlab Rescue Med Infant Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce…Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | Ventlab Corporation | 07/11/2012Terminated |
| Z-0178-2013 Class I | Ventlab Premium Small Adult Resuscitator, Manufactured by: Ventlab Corporation, 155…Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | Ventlab Corporation | 07/11/2012Terminated |
| Z-0177-2013 Class I | Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporation, 155…Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | Ventlab Corporation | 07/11/2012Terminated |
| Z-0176-2013 Class I | Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The Disposable…Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | Ventlab Corporation | 07/11/2012Terminated |