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The Tracker / August 2026 / K262515

510(k) cleared

Kneu Platform (V2)

Kneu Health Digital , Ltd. · Aug 20, 2026 · K262515

FDA cleared the Kneu Platform (V2) from Kneu Health Digital , Ltd. on Aug 20, 2026 under K262515, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code GYD, Transducer, Tremor, regulated at 21 CFR 882.1950 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jul 21, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K262515?

K262515 is the FDA 510(k) for Kneu Platform (V2), submitted by Kneu Health Digital , Ltd.. FDA's decision date was Aug 20, 2026, under product code GYD (Transducer, Tremor).

Who makes the Kneu Platform (V2)?

Kneu Health Digital , Ltd., based in London, is the applicant of record for K262515.

How long did the K262515 review take?

FDA received the submission on Jul 21, 2026 and issued its decision on Aug 20, 2026, 30 days later.

← All decisions in August 2026