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510(k) K250357

RemunityPRO™ Pump for Remodulin® (treprostinil) Injection by Deka Research & Development Corp. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2025
Date Received
February 7, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Deka Research & Development Corp.

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  • 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)
  • K234055 — DEKA Loop (March 13, 2024)

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  • K242115 — Plum Duo™ Precision IV Pump (April 2, 2025)
  • K242114 — Plum Solo™ Precision IV Pump (April 2, 2025)
  • K241736 — Remunity 2.0 Pump for Remodulin (treprostinil) Injection (January 16, 2025)
  • K242735 — Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Inf (December 23, 2024)
  • K242660 — Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curli (October 3, 2024)