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 | November 24, 2025 |
| K243861 | compact medical | butterflyBVM | April 25, 2025 |
| K221841 | archeon | EOlife® | March 18, 2023 |
| K212905 | safe bvm corporation | Sotair Device | August 18, 2022 |
| K210288 | xiamen compower medical tech. co | Disposable Manual Resuscitator | August 26, 2021 |
| K181583 | flexicare medical limited | Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resu | December 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 | August 29, 2016 |
| K132172 | laerdal medical | NEONATALIE RESUSCITATOR | January 15, 2015 |
| K112852 | a plus medical | BABI PLUS NEONATAL RESUSCITATION BAG | January 13, 2012 |
| K102824 | ambu | AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC | January 28, 2011 |
| K102649 | neoforce group | NEOPOP INFANT RESUSCITATOR WITH FLOW METER | January 6, 2011 |
| K094003 | hersill, s.l | REVIVATOR | September 17, 2010 |
| K093081 | microbvm systems | POCKET BVM | February 5, 2010 |
| K082092 | galemed | DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXE | October 15, 2008 |
| K073410 | artivent corporation | SAVE RESUSCITATOR | September 12, 2008 |
| K073171 | allied healthcare products | RESUSCITATION TIMER, MODEL L770-CPR | January 31, 2008 |
| K072021 | neoforce group | NEOPIP INFANT RESUSCITATOR | September 12, 2007 |
| K070247 | ohmeda medical | GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM | April 20, 2007 |
| K062080 | allied healthcare products | RESUSCITATION TIMER, MODEL L770-CPR | October 18, 2006 |