Cleared Traditional

Remunity System

K240256 · Deka Research and Development · General Hospital
Jun 2024
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K240256 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 and Development (Manchester, US). The FDA issued a Cleared decision on June 12, 2024, 133 days after receiving the submission on January 31, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K240256 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2024
Decision Date June 12, 2024
Days to Decision 133 days
Submission Type Traditional
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.