K250860 is an FDA 510(k) clearance for the BreatheBand® (Model 1000). This device is classified as a Percussor, Powered-electric (Class II - Special Controls, product code BYI).
Submitted by Exemplar Medical, LLC (Kansas City, US). The FDA issued a Cleared decision on October 2, 2025, 195 days after receiving the submission on March 21, 2025.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5665.
| 510(k) Number | K250860 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 2025 |
| Decision Date | October 02, 2025 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BYI - Percussor, Powered-electric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5665 |