FDA 510(k) Applications for Medical Device Product Code "BTM"
(Ventilator, Emergency, Manual (Resuscitator))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K112852 | A PLUS MEDICAL | BABI PLUS NEONATAL RESUSCITATION BAG | 01/13/2012 |
| K973106 | ALLIED HEALTHCARE PRODUCTS, INC. | GOLEMB DISPOSABLE BAG MASK RESUSCITATOR | 01/29/1998 |
| K014071 | ALLIED HEALTHCARE PRODUCTS, INC. | PMX DISPOSABLE BAG MASK RESUSCITATOR | 10/01/2002 |
| K073171 | ALLIED HEALTHCARE PRODUCTS, INC. | RESUSCITATION TIMER, MODEL L770-CPR | 01/31/2008 |
| K062080 | ALLIED HEALTHCARE PRODUCTS, INC. | RESUSCITATION TIMER, MODEL L770-CPR | 10/18/2006 |
| K053142 | AMBU A/S | AMBU MARK IV BABY RESUSCITATOR | 12/20/2005 |
| K053140 | AMBU A/S | AMBU MARK IV RESUSCITATOR | 12/23/2005 |
| K102824 | AMBU A/S | AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC | 01/28/2011 |
| K152931 | AMBU A/S | Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator | 08/29/2016 |
| K993278 | AMBU, INC. | AMBU NEONATE SILICONE RESUSCITATOR | 05/17/2000 |
| K042843 | AMBU, INC. | AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS | 11/12/2004 |
| K042682 | AMBU, INC. | AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR | 11/15/2004 |
| K964584 | AMBU, INC. | AMBU SPUR NEONATE | 05/15/1997 |
| K221841 | ARCHEON | EOlife« | 03/18/2023 |
| K073410 | ARTIVENT CORPORATION | SAVE RESUSCITATOR | 09/12/2008 |
| K031434 | BAWMED UK | BAWMED E-Z BAG RESUSCITATOR | 02/06/2004 |
| K021390 | CHEEN HOUNG ENT. CO. LTD. | PMX COMPACT RESUCITATOR | 10/04/2002 |
| K003927 | CHEEN HOUNG ENT. CO. LTD. | Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02 | 06/26/2001 |
| K243861 | Compact Medical, Inc. | butterflyBVM | 04/25/2025 |
| K051177 | DAVID MEDICAL PRODUCTS CO.,LTD | PVC AND SILICONE MANUAL RESUSCITATORS | 08/29/2005 |
| K972139 | DAVIS & GECK, INC. | ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOPE ADAPTER,IN-LINE SPECIMEN TRAP | 09/03/1997 |
| K991953 | ENGINEERED MEDICAL SYSTEMS | MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION | 07/01/1999 |
| K991955 | ENGINEERED MEDICAL SYSTEMS | MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION | 07/06/1999 |
| K042556 | ENTER MEDICAL CORPORATION | SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022, | 03/11/2005 |
| K181583 | Flexicare Medical Limited | 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 Si | 12/07/2018 |
| K170663 | Foremount Enterprise Co., Ltd. | Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer | 05/11/2018 |
| K082092 | GALEMED CORP. | DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE | 10/15/2008 |
| K955507 | GRAYCO, INC. | GRAYCO POCKET PUMP | 08/15/1996 |
| K002846 | HEADSTAR MEDICAL PRODUCTS CO., LTD | HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR | 06/06/2001 |
| K094003 | HERSILL, S.L. | REVIVATOR | 09/17/2010 |
| K053466 | HSINER CO., LTD. | HSINER RESUSCITATOR | 03/22/2006 |
| K964719 | HUDSON RESPIRATORY CARE, INC. | HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR | 02/21/1997 |
| K012271 | IMPOEX INTERNATIONAL, LTD. | ACUTEVENTILATOR | 10/04/2002 |
| K970959 | INSTRUMENTATION INDUSTRIES, INC. | INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT) | 06/13/1997 |
| K981308 | INTERNATIONAL RESPIRATORY SYSTEMS, INC. | INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL PULMONARY RESUSCITATOR WITH RUBBER COMPRESSION BAG | 07/06/1998 |
| K981307 | INTERNATIONAL RESPIRATORY SYSTEMS, INC. | INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR | 07/06/1998 |
| K132172 | LAERDAL MEDICAL A/S | NEONATALIE RESUSCITATOR | 01/15/2015 |
| K961329 | MEDICAL MARKETING CONCEPTS | BAGRIGHT CHILD RESUSCITATOR | 07/02/1996 |
| K961330 | MEDICAL MARKETING CONCEPTS | BAGRIGHT INFANT RESUSCITATOR | 07/02/1996 |
| K961331 | MEDICAL MARKETING CONCEPTS | BAGRIGHT RESPOSABLE CHILD RESUSCITATOR | 06/28/1996 |
| K961332 | MEDICAL MARKETING CONCEPTS | BAGRIGHT RESPOSABLE INFANT RESUSCITATOR | 06/28/1996 |
| K961369 | MEDICAL MARKETING CONCEPTS | BAGRIGHT RESPOSABLE RESUSCITATOR | 06/28/1996 |
| K953546 | MEDICAL MARKETING CONCEPTS | MANUAL PULMONARY RESUSICITATOR | 02/29/1996 |
| K982215 | MEDICAL MARKETING CONCEPTS | MANUAL RESUSCITATOR WITH ACE | 09/18/1998 |
| K961868 | MEDICAL MARKETING CONCEPTS | RESPOSABLE CHILD RESUSCITATOR | 06/28/1996 |
| K961882 | MEDICAL MARKETING CONCEPTS | RESPOSABLE INFANT RESUSCITATOR | 06/28/1996 |
| K954866 | MERCURY MEDICAL | MERCURY CPR (COMPLETE PERSONAL RESUSCIATOR) BAG WITH EXPANDABLE RESERVOIR | 01/30/1996 |
| K970756 | MERCURY MEDICAL | MERCURY MEDICAL REUSABLE CPR BAG | 10/31/1997 |
| K031395 | MERLIN MEDICAL LIMITED | MERLIN RESUSCITATOR | 07/16/2004 |
| K093081 | MICROBVM SYSTEMS LTD | POCKET BVM | 02/05/2010 |
| K973419 | NELLCOR PURITAN BENNETT, INC. | DMR PLUS DISPOSABLE MANUAL RESUSCITATOR | 03/25/1998 |
| K960468 | NELLCOR PURITAN BENNETT, INC. | DMR/CO2 COMBO KTI | 04/26/1996 |
| K023494 | NELLCOR PURITAN BENNETT, INC. | NELLCOR INDGO MANUAL RESUSCITATOR | 02/07/2003 |
| K072021 | NEOFORCE GROUP, INC. | NEOPIP INFANT RESUSCITATOR | 09/12/2007 |
| K102649 | NEOFORCE GROUP, INC. | NEOPOP INFANT RESUSCITATOR WITH FLOW METER | 01/06/2011 |
| K021328 | O-TWO SYSTEMS INTERNATIONAL INC. | SMART BAG MO | 06/26/2003 |
| K021446 | OEMEDIC INTERNATIONAL, INC. | OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR | 10/11/2002 |
| K021442 | OEMEDIC INTERNATIONAL, INC. | OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & RESERVOIR | 07/30/2002 |
| K070247 | OHMEDA MEDICAL | GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM | 04/20/2007 |
| K971243 | OHMEDA MEDICAL | OHMEDA INFANT RESUSCITATION SYSTEM | 12/02/1997 |
| K963848 | OWENS-BRIGAM MEDICAL CO. | MANUAL RESUSCITATOR | 07/07/1997 |
| K980066 | PLASCO, INC. | CPR FILTERSHIELD | 07/16/1998 |
| K021716 | POLYMED (XIAMEN) PLASTIC INDUSTRIAL CO.,LTD. | SIMPLIFY COMPACT RESUSCITATOR | 10/08/2002 |
| K023793 | PORTEX, INC. | 1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR | 02/11/2003 |
| K014115 | PORTEX, INC. | 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX | 02/27/2002 |
| K970991 | PROMEDIC, INC. | DATEX ENGSTOM MANUAL RESUSCITATOR | 06/16/1997 |
| K993194 | RUSCH, INC. | RUSCH MANUAL RESUSCITATOR BAG | 03/24/2000 |
| K212905 | Safe BVM Corporation | Sotair Device | 08/18/2022 |
| K974141 | SCHIFF & CO. | PLUS REUSABLE RESUSCITATOR | 05/21/1998 |
| K972283 | SIMS | SIMS 1ST RESPONSE MANUAL RESUSCITATOR, ADULT | 09/17/1997 |
| K991861 | SIMS PORTEX, INC. | 1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE | 01/18/2000 |
| K992057 | SIMS PORTEX, INC. | IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006 | 09/13/1999 |
| K032596 | STURDY INDUSTRIAL CO., LTD | STURDY MANUAL RESUSCITATOR | 08/05/2004 |
| K030864 | VEDI CORP. | VADI MANUAL RESUSCITATOR | 01/30/2004 |
| K012842 | VENTLAB CORP. | V*CARE MANUAL RESUSCITATOR | 09/18/2001 |
| K210288 | Xiamen Compower Medical Tech. Co., Ltd. | Disposable Manual Resuscitator | 08/26/2021 |
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