510(k) DEN250014
DEN250014 is an FDA 510(k) premarket notification submitted by Tyto Care , Ltd. for the device "Tyto Insights for Eardrum Bulging Detection". The FDA issued a decision of De Novo Granted on March 17, 2026. The device falls under product code SHL (Ear, Nose, And Throat Image Analyzer), a Class II device regulated under 21 CFR 874.4775. Tyto Care , Ltd. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- March 17, 2026
- Date Received
- April 21, 2025
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ear, Nose, And Throat Image Analyzer
- Device Class
- Class II
- Regulation Number
- 874.4775
- Review Panel
- EN
- Submission Type
An ear, nose, and throat image analyzer is a device that uses software to analyze patient-specific optical images of the ear, nose, and throat area. The results are provided to healthcare providers as an aid to detection, diagnosis, or monitoring of ear, nose, and throat conditions.