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510(k) K242693

DEKA Infusion System, DEKA Administration Set by Deka Research and Development Corporation — Product Code LDR

K242693 is an FDA 510(k) premarket notification submitted by Deka Research and Development Corporation for the device "DEKA Infusion System, DEKA Administration Set". The FDA issued a decision of Substantially Equivalent on October 7, 2024. The device falls under product code LDR (Controller, Infusion, Intravascular, Electronic), a Class II device regulated under 21 CFR 880.5725.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2024
Date Received
September 9, 2024
Clearance Type
Special
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 for product code LDR

  • 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)
  • K905497 — MASTER FLOW I.V. PUMPETTE (April 16, 1991)
  • K896907 — 3M IV FLOW REGULATOR (February 26, 1990)

FDA data resources