Medical Device Manufacturer · JP , Kanagawa

Sb-Kawasumi Laboratories, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2022

Total

Cleared

Denied

Sb-Kawasumi Laboratories, Inc. has 5 FDA 510(k) cleared medical devices. Based in Kanagawa, JP.

Latest FDA clearance: Nov 2025. Active since 2022. Primary specialty: General Hospital.

Browse the FDA 510(k) cleared devices submitted by Sb-Kawasumi Laboratories, Inc. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Regulatory Compliance Associates, Inc. (Rca) and Mic International.

Sb-Kawasumi Laboratories, Inc. is one of 79 FDA 510(k) medical device manufacturers from Japan in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Sb-Kawasumi Laboratories, Inc.

5 devices

1-5 of 5

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: Apr 27, 2026