K250882 is an FDA 510(k) clearance for the SANSA HSAT. This device is classified as a Ventilatory Effort Recorder (Class II - Special Controls, product code MNR).
Submitted by Huxley Medical (Atlanta, US). The FDA issued a Cleared decision on October 29, 2025, 219 days after receiving the submission on March 24, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K250882 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 2025 |
| Decision Date | October 29, 2025 |
| Days to Decision | 219 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MNR - Ventilatory Effort Recorder |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2375 |