Cleared Special

K042980 - HOSPIRA GEMSTAR INFUSION PUMP SYSTEM

K042980 is the FDA 510(k) clearance for HOSPIRA GEMSTAR INFUSION PUMP SYSTEM by Hospira, Inc.. It is a Class 2 General Hospital device (product code FRN) cleared through the Special 510(k) pathway after a 19-day FDA review.

K042980 · Hospira, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
19d
Days
Class 2
Risk

K042980 is an FDA 510(k) clearance for the HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECT SOFTWARE. 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 November 17, 2004 after a review of 19 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 K042980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2004
Decision Date November 17, 2004
Days to Decision 19 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
110d faster than avg
Panel avg: 129d · This submission: 19d
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 K042980.
MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C
K043600 · Medtronic Minimed · Mar 2005
PHARMGUARD TOOLBOX, MODEL G6000782
K042432 · Medex, Inc. · Jan 2005
PUMP CONNECTIVITY INTERFACE
K040985 · Baxter Healthcare Corp · Nov 2004
PAINPUMP1
K042405 · Stryker Corp. · Oct 2004
HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE
K042609 · Hospira, Inc. · Oct 2004
PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K042081 · Hospira, Inc. · Aug 2004