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510(k) K931173

PRIMARY ADMIN SET W/UNIV SP-MAN BELOW/ABV PUMP CH by Imed Corp. — Product Code FPA

K931173 is an FDA 510(k) premarket notification submitted by Imed Corp. for the device "PRIMARY ADMIN SET W/UNIV SP-MAN BELOW/ABV PUMP CH". The FDA issued a decision of Substantially Equivalent on April 15, 1994. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Imed Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1994
Date Received
March 8, 1993
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 Imed Corp.

  • K960512 — GEMINI PC-ITX (November 21, 1996)
  • K953896 — THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETS (March 20, 1996)
  • K950153 — VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) (August 24, 1995)
  • K951922 — ADMINISTRATION SETS WITH BALL FLOAT (July 19, 1995)
  • K950419 — THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS (June 21, 1995)
  • K944320 — VENTED/NON-VENTED GEMINI ADMINISTRATION SET (February 14, 1995)
  • K945070 — VERSASAE PLASTIC CANNULA- 11 GAUGE (January 13, 1995)
  • K933144 — GEMINI VOLUMETRIC INFUSION PUMP/CONTROLLER (October 12, 1993)
  • K924718 — SHROUDED NEEDLE DEVICES (June 18, 1993)
  • K921378 — IMED MODEL PC-4 VOLUMETRIC INFUSION PUMP/CONTROLLE (June 9, 1992)

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