Home / 510(k) Clearances / K153760

510(k) K153760

Volumetric Infusion Controller by DEKA Research & Development — Product Code LDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2016
Date Received
December 30, 2015
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 DEKA Research & Development

  • K243841 — Sparta Infusion Set for Insulin (August 1, 2025)
  • K250930 — twiist system (April 2, 2025)
  • K250357 — RemunityPRO™ Pump for Remodulin® (treprostinil) Injection (March 11, 2025)
  • K241736 — Remunity 2.0 Pump for Remodulin (treprostinil) Injection (January 16, 2025)
  • K243354 — Remunity System (November 27, 2024)
  • K240920 — HemoCare Bicarbonate Concentrate Set (BCS) (July 12, 2024)
  • K233557 — HemoCare Hemodialysis System (July 12, 2024)
  • K240256 — Remunity System (June 12, 2024)
  • K241178 — DEKA ACE Pump System (May 24, 2024)
  • K233952 — DEKA ACE Pump System (March 13, 2024)

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)
  • 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)