Cleared Traditional

Plum Duo? Precision IV Pump

K242115 · Icu Medical, Inc. · General Hospital
Apr 2025
Decision
257d
Days
Class 2
Risk

About This 510(k) Submission

K242115 is an FDA 510(k) clearance for the Plum Duo? Precision IV Pump, 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 April 2, 2025, 257 days after receiving the submission on July 19, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K242115 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 2024
Decision Date April 02, 2025
Days to Decision 257 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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