# Sb-Kawasumi Laboratories, Inc.

- Location (FDA's records): Kanagawa, JP
- FDA decisions: 5 (2022–2025): 5 510(k) clearances
- Product codes: JKA (3), PTI (1), KNS (1)
- 510(k) review time since 2016: median 120 days, against 171 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 5 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Becton, Dickinson & CO: 1 (https://510kreport.com/company/becton-dickinson)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)
- Sumitomo Bakelite Co., Ltd.: 1 (https://510kreport.com/company/sumitomo-bakelite)
- Kawasumi Laboratories Co., Ltd.: 1 (https://510kreport.com/company/kawasumi-laboratories)

## Its most-cited devices
- K220799: K-SHIELD Zen (2022), cited by 1

## Recent decisions
- K252355: K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing (Nov 26, 2025)
- K241855: SB Knife Jr2 (MD-47702 and MD-47702L) (Mar 26, 2025)
- K230408: K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) (Jun 1, 2023)
- K223810: Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) (Feb 24, 2023)
- K220799: K-SHIELD Zen (Aug 29, 2022)

Source page: https://510kreport.com/company/sb-kawasumi-laboratories