K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)— 510(k) K230408

Substantially Equivalent

Sb-Kawasumi Laboratories, Inc.

FDA 510(k) clearance K230408 for K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM), Substantially Equivalent on 2023-06-01. Applicant: Sb-Kawasumi Laboratories, Inc..

Clearance details

Applicant: Sb-Kawasumi Laboratories, Inc.
Product code: Code JKA
Advisory panel: Clinical Chemistry
Date received: 2023-02-15
Decision date: 2023-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kanagawa, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code JKA

product code JKA

Injury: 455
Malfunction: 26,686
Other: 4
Total: 27,145

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.