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510(k) K243354

Remunity System by Deka Research & Development Corp. — Product Code QJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2024
Date Received
October 29, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Infusion Pump, Drug Specific, Pharmacy-Filled
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

A Pharmacy-Filled, Drug Specific Infusion System is a prescription device intended for delivery of a specific drug in accordance with the FDA approved labeling and may be filled at a location other than point of care.

Other clearances by Deka Research & Development Corp.

  • 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)
  • 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)

Other clearances for product code QJY

  • K240256 — Remunity System (June 12, 2024)
  • K202690 — Remunity Pump for Remodulin (treprostinil) Injection (December 30, 2020)
  • K191313 — Unity Subcutaneous Infusion System for Remodulin (February 21, 2020)