Panels › Anesthesiology › Product code BTM · Class 2
Ventilator, Emergency, Manual (Resuscitator)
Regulation 868.5915
2510(k)s in 12 months (210 all time)
1recalls in 12 months (97 all time)
80recalls that name a 510(k)
Top companies in BTM
| Company | 510(k)s | Recalls |
|---|---|---|
| Unomedical | 0 | 23 |
| Ventlab Corp. | 2 | 19 |
| Ambu, Inc. | 15 | 1 |
| Sun Med, LLC | 0 | 14 |
| Puritan Bennett Corp. | 13 | 0 |
| Medical Marketing Concepts | 11 | 0 |
| Vyaire Medical | 0 | 11 |
| SunMed Holdings, LLC | 0 | 10 |
| Laerdal Medical AS | 3 | 4 |
| Life Design Systems, Inc. | 7 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 16, 2026 | K263254 | Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1) Xiamen Compower Medical Tech. Co., Ltd., CN | BTM |
| Nov 24, 2025 | K251631 | The BAG manual resuscitator and accessories Laerdal Medical AS, NO | BTM |
| Apr 25, 2025 | K243861 | butterflyBVM Compact Medical, Inc. | BTM |
| Mar 18, 2023 | K221841 | EOlife® Archeon, FR | BTM |
| Aug 18, 2022 | K212905 | Sotair Device Safe Bvm Corporation | BTM |
| Aug 26, 2021 | K210288 | Disposable Manual Resuscitator Xiamen Compower Medical Tech. Co., Ltd., CN | BTM |
| Dec 7, 2018 | K181583 | Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Flexicare Medical Limited., GB | BTM |
| May 11, 2018 | K170663 | Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer Foremount Enterprise Co., Ltd., TW | BTM |
| Aug 29, 2016 | K152931 | Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator Ambu A/S, DK | BTM |
| Jan 15, 2015 | K132172 | NEONATALIE RESUSCITATOR Laerdal Medical A/S, NO | BTM |
| Jan 13, 2012 | K112852 | BABI PLUS NEONATAL RESUSCITATION BAG A Plus Medical | BTM |
| Jan 28, 2011 | K102824 | AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC Ambu A/S | BTM |
| Jan 6, 2011 | K102649 | NEOPOP INFANT RESUSCITATOR WITH FLOW METER Neoforce Group, Inc. | BTM |
| Sep 17, 2010 | K094003 | REVIVATOR Hersill, S.L., ES | BTM |
| Feb 5, 2010 | K093081 | POCKET BVM Microbvm Systems , Ltd., IL | BTM |
| Oct 15, 2008 | K082092 | DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE Galemed Corp. | BTM |
| Sep 12, 2008 | K073410 | SAVE RESUSCITATOR Artivent Corporation | BTM |
| Jan 31, 2008 | K073171 | RESUSCITATION TIMER, MODEL L770-CPR Allied Healthcare Products, Inc. | BTM |
| Sep 12, 2007 | K072021 | NEOPIP INFANT RESUSCITATOR Neoforce Group, Inc. | BTM |
| Apr 20, 2007 | K070247 | GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM Ohmeda Medical | BTM |
| Oct 18, 2006 | K062080 | RESUSCITATION TIMER, MODEL L770-CPR Allied Healthcare Products, Inc. | BTM |
| Mar 22, 2006 | K053466 | HSINER RESUSCITATOR Hsiner Co., Ltd. | BTM |
| Dec 23, 2005 | K053140 | AMBU MARK IV RESUSCITATOR Ambu A/S | BTM |
| Dec 20, 2005 | K053142 | AMBU MARK IV BABY RESUSCITATOR Ambu A/S | BTM |
| Aug 29, 2005 | K051177 | PVC AND SILICONE MANUAL RESUSCITATORS David Medical Products Co.,Ltd, CN | BTM |
| Mar 11, 2005 | K042556 | SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022, Enter Medical Corporation, TW | BTM |
| Nov 15, 2004 | K042682 | AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR Ambu, Inc. | BTM |
| Nov 12, 2004 | K042843 | AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS Ambu, Inc. | BTM |
| Aug 5, 2004 | K032596 | STURDY MANUAL RESUSCITATOR Sturdy Industrial Co., Ltd. | BTM |
| Jul 16, 2004 | K031395 | MERLIN RESUSCITATOR Merlin Medical Limited, GB | BTM |
| Feb 6, 2004 | K031434 | BAWMED E-Z BAG RESUSCITATOR Bawmed UK, GB | BTM |
| Jan 30, 2004 | K030864 | VADI MANUAL RESUSCITATOR Vedi Corp. | BTM |
| Jun 26, 2003 | K021328 | SMART BAG MO O-Two Systems International, Inc., CA | BTM |
| Feb 11, 2003 | K023793 | 1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR Portex, Inc. | BTM |
| Feb 7, 2003 | K023494 | NELLCOR INDGO MANUAL RESUSCITATOR Nellcor Puritan Bennett, Inc. | BTM |
| Oct 11, 2002 | K021446 | OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR Oemedic International, Inc. | BTM |
| Oct 8, 2002 | K021716 | SIMPLIFY COMPACT RESUSCITATOR Polymed (Xiamen) Plastic Industrial Co., Ltd., CN | BTM |
| Oct 4, 2002 | K021390 | PMX COMPACT RESUCITATOR Cheen Houng Ent. Co. , Ltd., TW | BTM |
| Oct 4, 2002 | K012271 | ACUTEVENTILATOR Impoex International, Ltd. | BTM |
| Oct 1, 2002 | K014071 | PMX DISPOSABLE BAG MASK RESUSCITATOR Allied Healthcare Products, Inc. | BTM |
| Jul 30, 2002 | K021442 | OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & RESERVOIR Oemedic International, Inc. | BTM |
| Feb 27, 2002 | K014115 | 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX Portex, Inc. | BTM |
| Sep 18, 2001 | K012842 | V*CARE MANUAL RESUSCITATOR Ventlab Corp. | BTM |
| Jun 26, 2001 | K003927 | Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02 Cheen Houng Ent. Co. , Ltd., TW | BTM |
| Jun 6, 2001 | K002846 | HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR Headstar Medical Products Co., Ltd., CN | BTM |
| May 17, 2000 | K993278 | AMBU NEONATE SILICONE RESUSCITATOR Ambu, Inc. | BTM |
| Mar 24, 2000 | K993194 | RUSCH MANUAL RESUSCITATOR BAG Rusch, Inc. | BTM |
| Jan 18, 2000 | K991861 | 1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE Sims Portex, Inc. | BTM |
| Sep 13, 1999 | K992057 | IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006 Sims Portex, Inc. | BTM |
| Jul 6, 1999 | K991955 | MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION Engineered Medical Systems | BTM |
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