Product code BTM
- Device name
- Ventilator, Emergency, Manual (Resuscitator)
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5915
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251631 | The BAG manual resuscitator and accessories | Laerdal Medical AS | 2025-11-24 |
| K243861 | butterflyBVM | Compact Medical, Inc. | 2025-04-25 |
| K221841 | EOlife® | Archeon | 2023-03-18 |
| K212905 | Sotair Device | Safe Bvm Corporation | 2022-08-18 |
| K210288 | Disposable Manual Resuscitator | Xiamen Compower Medical Tech. Co., Ltd. | 2021-08-26 |
| K181583 | 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 ... | Flexicare Medical Limited. | 2018-12-07 |
| K170663 | Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer | Foremount Enterprise Co., Ltd. | 2018-05-11 |
| K152931 | Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator | Ambu A/S | 2016-08-29 |
| K132172 | NEONATALIE RESUSCITATOR | Laerdal Medical A/S | 2015-01-15 |
| K112852 | BABI PLUS NEONATAL RESUSCITATION BAG | A Plus Medical | 2012-01-13 |
| K102824 | AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC | Ambu A/S | 2011-01-28 |
| K102649 | NEOPOP INFANT RESUSCITATOR WITH FLOW METER | Neoforce Group, Inc. | 2011-01-06 |
| K094003 | REVIVATOR | Hersill, S.L. | 2010-09-17 |
| K093081 | POCKET BVM | Microbvm Systems , Ltd. | 2010-02-05 |
| K082092 | DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE | Galemed Corp. | 2008-10-15 |
| K073410 | SAVE RESUSCITATOR | Artivent Corporation | 2008-09-12 |
| K073171 | RESUSCITATION TIMER, MODEL L770-CPR | Allied Healthcare Products, Inc. | 2008-01-31 |
| K072021 | NEOPIP INFANT RESUSCITATOR | Neoforce Group, Inc. | 2007-09-12 |
| K070247 | GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM | Ohmeda Medical | 2007-04-20 |
| K062080 | RESUSCITATION TIMER, MODEL L770-CPR | Allied Healthcare Products, Inc. | 2006-10-18 |
| K053466 | HSINER RESUSCITATOR | Hsiner Co., Ltd. | 2006-03-22 |
| K053140 | AMBU MARK IV RESUSCITATOR | Ambu A/S | 2005-12-23 |
| K053142 | AMBU MARK IV BABY RESUSCITATOR | Ambu A/S | 2005-12-20 |
| K051177 | PVC AND SILICONE MANUAL RESUSCITATORS | David Medical Products Co.,Ltd | 2005-08-29 |
| K042556 | SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022, | Enter Medical Corporation | 2005-03-11 |
| K042682 | AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR | Ambu, Inc. | 2004-11-15 |
| K042843 | AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS | Ambu, Inc. | 2004-11-12 |
| K032596 | STURDY MANUAL RESUSCITATOR | Sturdy Industrial Co., Ltd. | 2004-08-05 |
| K031395 | MERLIN RESUSCITATOR | Merlin Medical Limited | 2004-07-16 |
| K031434 | BAWMED E-Z BAG RESUSCITATOR | Bawmed UK | 2004-02-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10080196659777 | Medline | MEDLINE INDUSTRIES, INC. | 2022-10-28 |
| 10190752114265 | AirLife™ | VYAIRE MEDICAL, INC. | 2020-02-04 |
| 10190752118706 | Vital Signs™ | AIRLIFE | 2020-01-15 |
| 10190752119895 | Vital Signs™ | AIRLIFE | 2019-12-20 |
| 10190752119642 | Vital Signs™ | AIRLIFE | 2019-12-20 |
| 10190752119666 | Vital Signs™ | AIRLIFE | 2019-12-20 |
| 10190752119673 | Vital Signs™ | AIRLIFE | 2019-12-20 |
| 10190752119697 | Vital Signs™ | AIRLIFE | 2019-12-20 |
| 10190752119703 | Vital Signs™ | AIRLIFE | 2019-12-20 |
| 10190752119789 | Vital Signs™ | AIRLIFE | 2019-12-20 |
| 10190752119833 | Vital Signs™ | VYAIRE MEDICAL, INC. | 2019-12-20 |
| 10190752119857 | Vital Signs™ | AIRLIFE | 2019-12-20 |
| 10190752119581 | Vital Signs™ | AIRLIFE | 2019-12-20 |
| 10190752119918 | Vital Signs™ | AIRLIFE | 2019-12-20 |
| 10190752119994 | Vital Signs™ | AIRLIFE | 2019-12-20 |
| 10190752120006 | Vital Signs™ | AIRLIFE | 2019-12-20 |
| 10190752120013 | Vital Signs™ | AIRLIFE | 2019-12-20 |
| 10190752119635 | Vital Signs™ | AIRLIFE | 2019-12-20 |
| 10190752119574 | Vital Signs™ | VYAIRE MEDICAL, INC. | 2019-12-20 |
| 10190752119543 | Vital Signs™ | AIRLIFE | 2019-12-20 |
| 10190752119536 | Vital Signs™ | AIRLIFE | 2019-12-20 |
| 10190752119512 | Vital Signs™ | AIRLIFE | 2019-12-20 |
| 10190752119383 | Vital Signs™ | AIRLIFE | 2019-12-20 |
| 10190752119376 | Vital Signs™ | AIRLIFE | 2019-12-20 |
| 10190752119369 | Vital Signs™ | AIRLIFE | 2019-12-20 |
| 10190752119338 | Vital Signs™ | AIRLIFE | 2019-12-20 |
| 10190752119253 | Vital Signs™ | AIRLIFE | 2019-12-20 |
| 10080196521142 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2015-10-15 |
| 10080196522231 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2015-10-09 |
| 10080196522217 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2015-10-09 |