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510(k) K852254

I.V. STAT MASTER by The Master Medical Corp. — Product Code FPA

K852254 is an FDA 510(k) premarket notification submitted by The Master Medical Corp. for the device "I.V. STAT MASTER". The FDA issued a decision of Substantially Equivalent on November 18, 1985. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. The Master Medical Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1985
Date Received
May 24, 1985
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 The Master Medical Corp.

  • K913076 — I.V. INSTANT TIMER (October 17, 1991)
  • K905497 — MASTER FLOW I.V. PUMPETTE (April 16, 1991)
  • K905498 — STAT 2 IV PUMPETTE (April 16, 1991)
  • K871753 — MASTER MEDICAL DEVICE IS I.V. STAT 2 (June 5, 1987)
  • K792560 — MASTER I.V. DIAL LOCK (December 20, 1979)

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