Cleared Traditional

DEKA Infusion System, DEKA Administration Set

K232316 · Deka Research and Development · General Hospital
Mar 2024
Decision
211d
Days
Class 2
Risk

About This 510(k) Submission

K232316 is an FDA 510(k) clearance for the DEKA Infusion System, DEKA Administration Set, a Controller, Infusion, Intravascular, Electronic (Class II — Special Controls, product code LDR), submitted by Deka Research and Development (Manchester, US). The FDA issued a Cleared decision on March 1, 2024, 211 days after receiving the submission on August 3, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K232316 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 2023
Decision Date March 01, 2024
Days to Decision 211 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LDR — Controller, Infusion, Intravascular, Electronic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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