K251494 is an FDA 510(k) clearance for the Eko Foundation Analysis Software with Transformers (EFAST). This device is classified as a Stethoscope, Electronic (Class II - Special Controls, product code DQD).
Submitted by Eko Health, Inc. (Emeryville, US). The FDA issued a Cleared decision on August 12, 2025, 89 days after receiving the submission on May 15, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1875.
| 510(k) Number | K251494 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 2025 |
| Decision Date | August 12, 2025 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQD - Stethoscope, Electronic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1875 |