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

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K030385 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

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 Laboratory Blood Drawing Kit

  Class II

  FDA 510(k) K001043 Active Cleared 19 May 2000

• 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

• Kawasumi Laboratories IV Administration Set, Primary

  Class II

  FDA 510(k) K001423 Active Cleared 21 Jul 2000