Cleared Traditional

K161469 - Plum 360(TM) Infusion System with MedNe...

K161469 is the FDA 510(k) clearance for Plum 360(TM) Infusion System with MedNe... by Hospira, Inc.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 305-day FDA review.

K161469 · Hospira, Inc. · General Hospital
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Mar 2017
Decision
305d
Days
Class 2
Risk

K161469 is an FDA 510(k) clearance for the Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Hospira, Inc. (Lake Forest, US). The FDA issued a Cleared decision on March 28, 2017 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Hospira, Inc. devices

Submission Details

510(k) Number K161469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2016
Decision Date March 28, 2017
Days to Decision 305 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
176d slower than avg
Panel avg: 129d · This submission: 305d
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 373
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K161469.
Power Infuser
K172653 · ZOLL Medical Corporation · Jul 2018
Perfusor® Space Syringe Infusion Pump System
K172831 · B.Braun Medical, Inc. · Jun 2018
Spectrum IQ Infusion System, Dose IQ Safety Software
K173084 · Baxter Healthcare Corporation · May 2018
Infusomat Space Volumetric Infusion Pump
K142596 · B.Braun Medical, Inc. · Jun 2015
PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE
K141789 · Hospira, Inc. · Jan 2015
HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE
K141102 · Hospira, Inc. · Jul 2014