Clearance Summary
Tyto Insights for Eardrum Bulging Detection received FDA 510(k) clearance under submission number DEN250014, sponsored by Tyto Care , Ltd.. The device was reviewed via the Direct premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2026-03-17.
- Submission: DEN250014
- Applicant / Sponsor: Tyto Care , Ltd.
- Clearance pathway: Direct
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4775
- Decision date: 2026-03-17
Classification & Regulation
This clearance is catalogued under FDA product code SHL and 21 CFR 874.4775, within the Ear, Nose, Throat review panel as a Class II device.