DeviceSignal · 510(k) cleared
Shokz Health Global Limited
FDA 510(k) decision recorded 2026-08-19 · K253431 · Traditional 510(k)
Event510(k) cleared
Effective2026-08-19
DecisionSESE
On 2026-08-19 the FDA recorded a 510(k) clearance decision for Shokz Health Global Limited, for Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN…. Clearance K253431. Product code LXB. A clearance is a regulatory decision, not an endorsement of the device.
Reported facts
- 510(k) number
- K253431
- Applicant
- Shokz Health Global Limited
- Device
- Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)
- Decided on
- 2026-08-19
- Received on
- 2025-10-01
- Decision
- SESE
- Clearance type
- Traditional
- Product code
- LXB
- Review days
- 322
Every field above is as fda_device_510k published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_510k
- Source record
K253431- Snapshot hash
a17b676375c92ad46cfd0c81b2c18852150764f05c544c0889e193548d652e00- Source URL
- https://download.open.fda.gov/device/510k/device-510k-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_510k_to_clearance v1- Event rule
fda_device_510k_cleared v1- Event key
7f8fb409e21ed16844f8bd9242b614f600a766d8a4f553b028bd712ef1d7fbb6- Signal type
device_clearance.granted
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)