DEN250014 is an FDA 510(k) submission for the Tyto Insights for Eardrum Bulging Detection..
Submitted by Tyto Care , Ltd. (Netanya, IL). The FDA issued a Not Cleared (DENG) decision on March 17, 2026.
This device falls under the Ear, Nose, Throat FDA review panel.
| 510(k) Number | DEN250014 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | April 21, 2025 |
| Decision Date | March 17, 2026 |
| Days to Decision | 330 days |
| Submission Type | Direct |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | SHL |
| Device Class | — |