| Decision | Number | Device | Company | Panel |
|---|---|---|---|---|
| 2026-06-02 | K252844 | Tyto Insights for Wheeze Detection (with PCCP) | Tyto Care , Ltd. | Anesthesiology |
| 2026-03-17 | DEN250014 | Tyto Insights for Eardrum Bulging Detection | Tyto Care , Ltd. | Ear Nose & Throat |
| 2026-03-12 | K252089 | Tyto Stethoscope (G3) | Tyto Care , Ltd. | Cardiovascular |
| 2025-04-07 | K243567 | Tyto Insights for Rhonchi Detection | Tyto Care , Ltd. | Anesthesiology |
| 2024-07-02 | K240555 | Tyto Insights for Crackles Detection | Tyto Care Ltd. | Anesthesiology |
| 2023-12-13 | K232237 | Tyto Insights for Wheeze Detection | Tyto Care Ltd. | Anesthesiology |
| 2016-10-19 | K160401 | Tyto Stethoscope | Tyto Care Ltd. | Cardiovascular |