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The Tracker / August 2026 / K253431

510(k) cleared

Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)

Shokz Health Global Limited · Aug 19, 2026 · K253431

FDA cleared the Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN) from Shokz Health Global Limited on Aug 19, 2026 under K253431, a traditional 510(k). The device falls under product code LXB, Hearing Aid, Bone Conduction, regulated at 21 CFR 874.3302 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Oct 1, 2025. The decision came 322 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 Shokz Health Global Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253431?

K253431 is the FDA 510(k) for Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN), submitted by Shokz Health Global Limited. FDA's decision date was Aug 19, 2026, under product code LXB (Hearing Aid, Bone Conduction).

Who makes the Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)?

Shokz Health Global Limited, based in Kowloon, is the applicant of record for K253431.

How long did the K253431 review take?

FDA received the submission on Oct 1, 2025 and issued its decision on Aug 19, 2026, 322 days later.

← All decisions in August 2026