Cleared Traditional

K253431 - Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)

K253431 is an FDA 510(k) clearance for Bone conduction Hearing Aid (BM100, manufactured by Shokz Health Global Limited. The device is a Class 2 Ear, Nose, Throat device with product code LXB cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K253431 · Shokz Health Global Limited · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
322d
Days
Class 2
Risk

K253431 is an FDA 510(k) clearance for the Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM40.... Classified as Hearing Aid, Bone Conduction (product code LXB), Class II - Special Controls.

Submitted by Shokz Health Global Limited (Kowloon, HK). The FDA issued a Cleared decision on August 19, 2026 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3302 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Shokz Health Global Limited devices

FDA 510(k) Submission Details - K253431

510(k) Number K253431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2025
Decision Date August 19, 2026
Days to Decision 322 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
232d slower than avg
Panel avg: 90d · This submission: 322d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LXB Device Classification - Class 2, Special Controls

Product Code LXB Hearing Aid, Bone Conduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3302
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Consultant

Shenzhen Reanny Medical Devices Management Consulting Co., Ltd.
Reanny Wang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LXB Hearing Aid, Bone Conduction

All 34
Devices cleared under the same product code (LXB) and FDA review panel - the closest regulatory comparables to K253431.
Ossiclear (Ossiclear System)
K254296 · Sounduct · Jul 2026
Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158)
K260452 · Zdeer Technology (Henan) Co., Ltd. · Jun 2026
Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)
K261256 · Shenzhen Magnet Technology Co., Ltd. · Jun 2026
Baha 7 Sound Processor
K250215 · Cochlear · May 2025
contact forte Alpha
K243041 · Bhm-Tech Produktionsgesellschaft Mbh · Apr 2025
Ponto 5 SuperPower
K213733 · Oticon Medical AB · Dec 2021