K251631 is an FDA 510(k) clearance for the The BAG manual resuscitator and accessories. This device is classified as a Ventilator, Emergency, Manual (resuscitator) (Class II - Special Controls, product code BTM).
Submitted by Laerdal Medical AS (Stavanger, NO). The FDA issued a Cleared decision on November 24, 2025, 180 days after receiving the submission on May 28, 2025.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5915.
| 510(k) Number | K251631 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 28, 2025 |
| Decision Date | November 24, 2025 |
| Days to Decision | 180 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTM - Ventilator, Emergency, Manual (resuscitator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5915 |