# Kawasumi Laboratories America, Inc.

- Location (FDA's records): Tampa, FL
- FDA decisions: 6 (2000–2010): 6 510(k) clearances
- Product codes: FPA (5), KSB (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 2 (0 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
- Kawasumi Laboratories Co., Ltd.: 1 (https://510kreport.com/company/kawasumi-laboratories)
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 1 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)

## Firms that cite its devices most
- Kawasumi Laboratories Co., Ltd.: 2 (https://510kreport.com/company/kawasumi-laboratories)

## Its most-cited devices
- K001043: Kawasumi Laboratory Blood Drawing Kit (2000), cited by 2

## Recent decisions
- K102890: K-Shield Small Vein Infusion / Winged Collection Set W/ Anti Needle Stick Protector (and Multisample Luer Adapter) (Oct 21, 2010)
- K030385: IV Add-on Filter Administration Set with and Without Y Connect or Needleless Access Connector (Apr 15, 2003)
- K001426: Kawasumi Laboratories IV Administration Set with Filter (Jul 21, 2000)
- K001423: Kawasumi Laboratories IV Administration Set, Primary (Jul 21, 2000)
- K001424: Kawasumi Laboratories IV Administration Set, Standard (Jul 21, 2000)
- K001043: Kawasumi Laboratory Blood Drawing Kit (May 19, 2000)

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