Clearance Summary
Tuned Self-Fitting Mobile App received FDA 510(k) clearance under submission number K251208, sponsored by Tuned , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2025-09-26.
- Submission: K251208
- Applicant / Sponsor: Tuned , Ltd.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3335
- Decision date: 2025-09-26
Classification & Regulation
This clearance is catalogued under FDA product code SCR and 21 CFR 874.3335, within the Ear, Nose, Throat review panel as a Class II device.