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510(k) K090012

DISPOSABLE INFUSION SET by Shan Dong Wei Gao Group Medical Polymer Products — Product Code FPA

K090012 is an FDA 510(k) premarket notification submitted by Shan Dong Wei Gao Group Medical Polymer Products for the device "DISPOSABLE INFUSION SET". The FDA issued a decision of Substantially Equivalent on June 11, 2009. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Shan Dong Wei Gao Group Medical Polymer Products has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2009
Date Received
January 2, 2009
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 Shan Dong Wei Gao Group Medical Polymer Products

  • K090459 — DISPOSABLE TPE INFUSION SET (October 13, 2009)
  • K083349 — BLOOD TRANSFUSION SET (April 10, 2009)

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