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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / September 2025 / K251208

510(k) cleared

Tuned Self-Fitting Mobile App

Tuned , Ltd. · Sep 26, 2025 · K251208

FDA cleared the Tuned Self-Fitting Mobile App from Tuned , Ltd. on Sep 26, 2025 under K251208, a traditional 510(k). The device falls under product code SCR, Air-Conduction Hearing Aid Software, regulated at 21 CFR 874.3335 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Apr 18, 2025. The decision came 161 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Tuned , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251208?

K251208 is the FDA 510(k) for Tuned Self-Fitting Mobile App, submitted by Tuned , Ltd.. FDA's decision date was Sep 26, 2025, under product code SCR (Air-Conduction Hearing Aid Software).

Who makes the Tuned Self-Fitting Mobile App?

Tuned , Ltd., based in Gan Yoshiya, is the applicant of record for K251208.

How long did the K251208 review take?

FDA received the submission on Apr 18, 2025 and issued its decision on Sep 26, 2025, 161 days later.

← All decisions in September 2025