BTM — Ventilator, Emergency, Manual (Resuscitator) Class II
FDA product code BTM covers "Ventilator, Emergency, Manual (Resuscitator)", a Class II medical device regulated under 21 CFR 868.5915. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- BTM
- Device Class
- Class II
- Regulation Number
- 868.5915
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251631 | Laerdal Medical | The BAG manual resuscitator and accessories | Nov 24, 2025 |
| K243861 | Compact Medical | butterflyBVM | Apr 25, 2025 |
| K221841 | Archeon | EOlife® | Mar 18, 2023 |
| K212905 | Safe Bvm Corporation | Sotair Device | Aug 18, 2022 |
| K210288 | Xiamen Compower Medical Tech. Co | Disposable Manual Resuscitator | Aug 26, 2021 |
| K181583 | Flexicare Medical Limited | Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resu | Dec 7, 2018 |
| K170663 | Foremount Enterprise Co | Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremoun | May 11, 2018 |
| K152931 | Ambu | Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR | Aug 29, 2016 |
| K132172 | Laerdal Medical | NEONATALIE RESUSCITATOR | Jan 15, 2015 |
| K112852 | A Plus Medical | BABI PLUS NEONATAL RESUSCITATION BAG | Jan 13, 2012 |
| K102824 | Ambu | AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC | Jan 28, 2011 |
| K102649 | Neoforce Group | NEOPOP INFANT RESUSCITATOR WITH FLOW METER | Jan 6, 2011 |
| K094003 | Hersill, S.L | REVIVATOR | Sep 17, 2010 |
| K093081 | Microbvm Systems | POCKET BVM | Feb 5, 2010 |
| K082092 | Galemed | DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXE | Oct 15, 2008 |
| K073410 | Artivent Corporation | SAVE RESUSCITATOR | Sep 12, 2008 |
| K073171 | Allied Healthcare Products | RESUSCITATION TIMER, MODEL L770-CPR | Jan 31, 2008 |
| K072021 | Neoforce Group | NEOPIP INFANT RESUSCITATOR | Sep 12, 2007 |
| K070247 | Ohmeda Medical | GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM | Apr 20, 2007 |
| K062080 | Allied Healthcare Products | RESUSCITATION TIMER, MODEL L770-CPR | Oct 18, 2006 |