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510(k) K953474

IV START KIT by Medikmark, Inc. — Product Code FPA

K953474 is an FDA 510(k) premarket notification submitted by Medikmark, Inc. for the device "IV START KIT". The FDA issued a decision of Substantially Equivalent on October 2, 1995. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Medikmark, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1995
Date Received
July 24, 1995
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 Medikmark, Inc.

  • K923960 — UPPER EXTERMITY DRAPE KIT (October 7, 1994)
  • K921730 — C-SECTION PACK (June 15, 1994)
  • K921733 — TRACHEOSTOMY CARE TRAY (June 15, 1994)
  • K921732 — MINOR LAP SET (June 15, 1994)
  • K920339 — DRESSING CHANGE TRAY (April 23, 1992)
  • K920341 — LACERATION TRAYS (April 23, 1992)
  • K920340 — SUTURE REMOVAL KIT (April 23, 1992)

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