Cleared Special

K141102 - HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE

K141102 is the FDA 510(k) clearance for HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE by Hospira, Inc.. It is a Class 2 General Hospital device (product code FRN) cleared through the Special 510(k) pathway after a 70-day FDA review.

K141102 · Hospira, Inc. · General Hospital
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Jul 2014
Decision
70d
Days
Class 2
Risk

K141102 is an FDA 510(k) clearance for the HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE. 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 July 8, 2014 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Hospira, Inc. devices

Submission Details

510(k) Number K141102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2014
Decision Date July 08, 2014
Days to Decision 70 days
Submission Type Special
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
59d faster than avg
Panel avg: 129d · This submission: 70d
Pathway characteristics
Modification to existing cleared device.

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 K141102.
Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module
K161469 · Hospira, Inc. · Mar 2017
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
BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY
K133801 · Baxter Healthcare Corporation · May 2014
CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE
K111275 · Smiths Medical Asd, Inc. · Feb 2013
SYMBIQ INFUSION AND ADMINSTRATION SET
K110901 · Hospira, Inc. · Mar 2012