Cleared Traditional

K242115 - Plum Duo Precision IV Pump

K242115 is the FDA 510(k) clearance for Plum Duo Precision IV Pump by Icu Medical, Inc.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K242115 · Icu Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
257d
Days
Class 2
Risk

K242115 is an FDA 510(k) clearance for the Plum Duo™ Precision IV Pump. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Icu Medical, Inc. (Lake Forest, US). The FDA issued a Cleared decision on April 2, 2025 after a review of 257 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Icu Medical, Inc. devices

Submission Details

510(k) Number K242115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 129d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FRN Pump, Infusion

All 433
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K242115.
MRidium 3870 MRI Infusion Pump System (3870)
K242752 · Iradimed Corporation · May 2025
BD Alaris Infusion System with Guardrails Suite MX
K243855 · Carefusion 303, Inc. · Apr 2025
Plum Solo™ Precision IV Pump
K242114 · Icu Medical, Inc. · Apr 2025
RemunityPRO™ Pump for Remodulin® (treprostinil) Injection
K250357 · Deka Research & Development Corp. · Mar 2025
Remunity 2.0 Pump for Remodulin (treprostinil) Injection
K241736 · Deka Research and Development Corp. · Jan 2025
Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min)
K242735 · Belmont Medical Technologies · Dec 2024