Cleared Traditional

Plum Duo? Infusion System

K223607 · Icu Medical, Inc. · General Hospital
Aug 2023
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K223607 is an FDA 510(k) clearance for the Plum Duo? Infusion System, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Icu Medical, Inc. (Lake Forest, US). The FDA issued a Cleared decision on August 24, 2023, 265 days after receiving the submission on December 2, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K223607 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 2022
Decision Date August 24, 2023
Days to Decision 265 days
Submission Type Traditional
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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