Kawasumi Laboratory Blood Drawing Kit

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K001043 ↗

FDA Product Code

KSB

Device Class

Class II

Regulation

21 CFR Part 864.9875

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• K-Shield Small Vein Infusion / Winged Collection Set W/ Anti Needle Stick Protector (and Multisample Luer Adapter)

  Class II

  FDA 510(k) K102890 Active Cleared 21 Oct 2010

• Kawasumi Laboratories Iv Administration Set with Filter

  Class II

  FDA 510(k) K001426 Active Cleared 21 Jul 2000

• Kawasumi Laboratories Iv Administration Set, Standard

  Class II

  FDA 510(k) K001424 Active Cleared 21 Jul 2000

• Iv Add-on Filter Administration Set with and Without Y Connect or Needleless Access Connector

  Class II

  FDA 510(k) K030385 Active Cleared 15 Apr 2003

• Kawasumi Laboratories Iv Administration Set, Primary

  Class II

  FDA 510(k) K001423 Active Cleared 21 Jul 2000