# Kawasumi Laboratories Co., Ltd.

- Location (FDA's records): Tokyo, JP
- FDA decisions: 29 (1987–2019): 29 510(k) clearances
- Names in FDA's records: Kawasumi Laboratories Co., Ltd. (18); Kawasumi Laboratories, Inc. (11)
- Product codes: FPA (10), FMI (5), LJT (4), JKA (1), FOZ (1), FJI (1), KZD (1), KSB (1), FKQ (1), FJK (1), KPE (1), LHI (1)
- Predicates its devices cite: 15 (8 its own); citations of its devices by later devices: 10 (8 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medisystems Corp.: 2 (https://510kreport.com/company/medisystems)
- Kawasumi Laboratories America, Inc.: 2 (https://510kreport.com/company/kawasumi-laboratories-america)
- Becton Dickinson Vacutainer Systems: 1 (https://510kreport.com/company/becton-dickinson-vacutainer-systems)
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 1 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)

## Firms that cite its devices most
- Kawasumi Laboratories America, Inc.: 1 (https://510kreport.com/company/kawasumi-laboratories-america)
- Sb-Kawasumi Laboratories, Inc.: 1 (https://510kreport.com/company/sb-kawasumi-laboratories)

## Its most-cited devices
- K073257: Kawasumi Laboratories Large Wing Sets with Antineedle Stick Protector (2008), cited by 2
- K060580: K-Shield Port Access Infusion Set (2006), cited by 2
- K190485: Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) (2019), cited by 1
- K102994: K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector (2010), cited by 1
- K023917: Winged Needle Sets with an Antineedle Stick Protector (2003), cited by 1
- K123344: K-Shield Advantage Port Access Infusion Set (Pais) (2013), cited by 1

## Recent decisions
- K190485: Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) (Jul 8, 2019)
- K190233: K-Shield Advantage Port Access Infusion Set (PAIS) (May 2, 2019)
- K172957: Kawasumi Laboratories Blood Drawing Kit (BDK) System (Sep 28, 2018)
- K123344: K-Shield Advantage Port Access Infusion Set (Pais) (Mar 7, 2013)
- K100720: K-Shield Port Access Infusion Set with High Pressure Tubing (Nov 18, 2010)
- K102994: K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector (Nov 3, 2010)
- K073257: Kawasumi Laboratories Large Wing Sets with Antineedle Stick Protector (Jan 25, 2008)
- K061197: Kawasumi Laboratories Empty Solution Container (Jun 30, 2006)

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