BTM
- Product code
- BTM
- Device name
- Ventilator, Emergency, Manual (Resuscitator)
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.5915
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Life-sustaining / life-supporting
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 209 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251631 | 2025-11-24 | Laerdal Medical AS | The BAG manual resuscitator and accessories | |
| K243861 | 2025-04-25 | Compact Medical, Inc. | butterflyBVM |
Official FDA classification page: BTM
Classification and pathway per current FDA publications. Data from openFDA (CC0).