Cleared Special

RemunityPRO? Pump for Remodulin? (treprostinil) Injection

K250357 · Deka Research & Development Corp. · General Hospital
Mar 2025
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K250357 is an FDA 510(k) clearance for the RemunityPRO? Pump for Remodulin? (treprostinil) Injection, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Deka Research & Development Corp. (Manchester, US). The FDA issued a Cleared decision on March 11, 2025, 32 days after receiving the submission on February 7, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K250357 FDA.gov
FDA Decision Cleared SESE
Date Received February 07, 2025
Decision Date March 11, 2025
Days to Decision 32 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FRN — Pump, Infusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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