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510(k) K896896

KAWASUMI SMALL VEIN INFUSION SET by Kawasumi Laboratories Co., Ltd. — Product Code FPA

K896896 is an FDA 510(k) premarket notification submitted by Kawasumi Laboratories Co., Ltd. for the device "KAWASUMI SMALL VEIN INFUSION SET". The FDA issued a decision of Substantially Equivalent on September 12, 1990. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Kawasumi Laboratories Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1990
Date Received
December 8, 1989
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 Co., Ltd.

  • K994323 — KAWASUMI LABORATORIES PHILEBOTOMY SET (March 8, 2000)
  • K974829 — NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET) (February 12, 1998)
  • K964117 — NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE (March 14, 1997)
  • K935514 — VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDER (February 10, 1994)
  • K935506 — MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION (February 3, 1994)
  • K935505 — WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER (February 3, 1994)
  • K930012 — KAWASUMI LABORATORIES K-CUFF (December 14, 1993)
  • K921901 — PORT ACCESS INFUSION SET (September 10, 1993)
  • K921902 — PORT ACCESS NEEDLE (July 28, 1993)
  • K923323 — INTERMITTENT INJECTION SITE (July 13, 1993)

Other clearances for product code FPA

  • 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)
  • K250616 — Clave™ Neutral-Displacement Needlefree Connectors (June 5, 2025)

FDA data resources