Cleared Special

K043256 - HOSPIRA LIFECARE INFUSION SYSTEM

Also marketed or referenced as:
LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03

K043256 is the FDA 510(k) clearance for HOSPIRA LIFECARE INFUSION SYSTEM by Hospira, Inc.. It is a Class 2 General Hospital device (product code MEA) cleared through the Special 510(k) pathway after a 12-day FDA review.

K043256 · Hospira, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
12d
Days
Class 2
Risk

K043256 is an FDA 510(k) clearance for the HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07. Classified as Pump, Infusion, Pca (product code MEA), Class II - Special Controls.

Submitted by Hospira, Inc. (Lake Forest, US). The FDA issued a Cleared decision on December 6, 2004 after a review of 12 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 K043256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2004
Decision Date December 06, 2004
Days to Decision 12 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
117d faster than avg
Panel avg: 129d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MEA Pump, Infusion, Pca
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 - MEA Pump, Infusion, Pca

All 12
Devices cleared under the same product code (MEA) and FDA review panel - the closest regulatory comparables to K043256.
CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0
K130394 · Smiths Medical Asd, Inc. · Dec 2013
PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
K092313 · B.Braun Medical, Inc. · Nov 2009
MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM)
K051253 · Baxter Healthcare Corp · Jul 2005
LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K042800 · Hospira, Inc. · Oct 2004
SYNDEO PCA SYRINGE PUMP, MODEL 2L3113
K031566 · Baxter Healthcare Corp · Aug 2003
STRYKER PAINPUMP2
K030661 · Stryker Instruments · May 2003