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510(k) K191313

Unity Subcutaneous Infusion System for Remodulin by DEKA Research & Development — Product Code QJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2020
Date Received
May 15, 2019
Clearance Type
Traditional
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

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  • K250930 — twiist system (April 2, 2025)
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  • K241736 — Remunity 2.0 Pump for Remodulin (treprostinil) Injection (January 16, 2025)
  • K243354 — Remunity System (November 27, 2024)
  • K233557 — HemoCare Hemodialysis System (July 12, 2024)
  • K240920 — HemoCare Bicarbonate Concentrate Set (BCS) (July 12, 2024)
  • K240256 — Remunity System (June 12, 2024)
  • K241178 — DEKA ACE Pump System (May 24, 2024)
  • K234055 — DEKA Loop (March 13, 2024)

Other clearances for product code QJY

  • K243354 — Remunity System (November 27, 2024)
  • K240256 — Remunity System (June 12, 2024)
  • K202690 — Remunity Pump for Remodulin (treprostinil) Injection (December 30, 2020)