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510(k) K905497

MASTER FLOW I.V. PUMPETTE by The Master Medical Corp. — Product Code LDR

K905497 is an FDA 510(k) premarket notification submitted by The Master Medical Corp. for the device "MASTER FLOW I.V. PUMPETTE". The FDA issued a decision of Substantially Equivalent on April 16, 1991. The device falls under product code LDR (Controller, Infusion, Intravascular, Electronic), a Class II device regulated under 21 CFR 880.5725. The Master Medical Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1991
Date Received
December 7, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Infusion, Intravascular, Electronic
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by The Master Medical Corp.

  • K913076 — I.V. INSTANT TIMER (October 17, 1991)
  • K905498 — STAT 2 IV PUMPETTE (April 16, 1991)
  • K871753 — MASTER MEDICAL DEVICE IS I.V. STAT 2 (June 5, 1987)
  • K852254 — I.V. STAT MASTER (November 18, 1985)
  • K792560 — MASTER I.V. DIAL LOCK (December 20, 1979)

Other clearances for product code LDR

  • K242693 — DEKA Infusion System, DEKA Administration Set (October 7, 2024)
  • K232316 — DEKA Infusion System, DEKA Administration Set (March 1, 2024)
  • K153760 — Volumetric Infusion Controller (October 3, 2016)
  • K963136 — PACER MODEL 100 INFUSION CONTROLLER (October 10, 1997)
  • K971865 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P (July 3, 1997)
  • K971826 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500 (July 3, 1997)
  • K934543 — UNIVERSAL CONTROLLER, MODEL 100 (March 29, 1994)
  • K935236 — FLOW CONTROLLING EXTENSION SET (February 24, 1994)
  • K905498 — STAT 2 IV PUMPETTE (April 16, 1991)
  • K896907 — 3M IV FLOW REGULATOR (February 26, 1990)

FDA data resources