Home / 510(k) Clearances / K030385

510(k) K030385

IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR by Kawasumi Laboratories America, Inc. — Product Code FPA

K030385 is an FDA 510(k) premarket notification submitted by Kawasumi Laboratories America, Inc. for the device "IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR". The FDA issued a decision of Substantially Equivalent on April 15, 2003. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Kawasumi Laboratories America, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2003
Date Received
February 5, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Kawasumi Laboratories America, Inc.

  • K102890 — K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTEC (October 21, 2010)
  • K001423 — KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY (July 21, 2000)
  • K001424 — KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD (July 21, 2000)
  • K001426 — KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER (July 21, 2000)
  • K001043 — KAWASUMI LABORATORY BLOOD DRAWING KIT (May 19, 2000)

Other clearances for product code FPA

  • K254123 — Ecomed Disposable Administration Sets (September 11, 2026)
  • K261530 — iiSure Infusion Set (June 3, 2026)
  • K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, (May 4, 2026)
  • K251375 — PuraCath Firefly Needleless Connector IT (9005) (February 12, 2026)
  • K251257 — nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Fre (December 4, 2025)
  • K250325 — BD Alaris Pump Infusion Set (October 30, 2025)
  • K251814 — EZ™ IV Administration Set (August 29, 2025)
  • K251854 — SteadiSet infusion set (August 6, 2025)
  • K243841 — Sparta Infusion Set for Insulin (August 1, 2025)
  • K243392 — Infusomat® Space Volumetric Infusion Pump Administration Sets (July 24, 2025)

FDA data resources