Cleared Special

Remunity System

K243354 · Deka Research & Development Corp. · General Hospital
Nov 2024
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K243354 is an FDA 510(k) clearance for the Remunity System, a Infusion Pump, Drug Specific, Pharmacy-filled (Class II — Special Controls, product code QJY), submitted by Deka Research & Development Corp. (Manchester, US). The FDA issued a Cleared decision on November 27, 2024, 29 days after receiving the submission on October 29, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K243354 FDA.gov
FDA Decision Cleared SESE
Date Received October 29, 2024
Decision Date November 27, 2024
Days to Decision 29 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code QJY — Infusion Pump, Drug Specific, Pharmacy-filled
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725
Definition 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.