K252089 is an FDA 510(k) clearance for the Tyto Stethoscope (G3). This device is classified as a Stethoscope, Electronic (Class II - Special Controls, product code DQD).
Submitted by Tyto Care , Ltd. (Netanya, IL). The FDA issued a Cleared decision on March 12, 2026, 253 days after receiving the submission on July 2, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1875.
| 510(k) Number | K252089 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2025 |
| Decision Date | March 12, 2026 |
| Days to Decision | 253 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 |