FDA AI Clearance Tracker/DEN250014
Ear Nose & Throat · De Novo
Tyto Insights for Eardrum Bulging Detection
Tyto Care , Ltd.
About this listing
Tyto Insights for Eardrum Bulging Detection from Tyto Care , Ltd. appears on the U.S. FDA list of AI-enabled medical devices under submission DEN250014. It went through the De Novo pathway, reviewed by the Ear Nose & Throat panel, with an FDA decision dated March 17, 2026. Its primary FDA product code is SHL.
The FDA list records the regulatory facts above. For the device's cleared intended use, read the FDA decision summary linked at the bottom of this page.
- Device
- Tyto Insights for Eardrum Bulging Detection
- Company
- Tyto Care , Ltd.
- Submission number
- DEN250014
- Pathway
- De Novo
- Decision date
- Mar 17, 2026
- Specialty (lead panel)
- Ear Nose & Throat
- Primary product code
- SHL
More from Tyto Care , Ltd.
Source: U.S. FDA AI-Enabled Medical Devices list. The FDA says the list is not comprehensive. Confirm details on the FDA's own record.