Cleared Traditional

K143612 - LifeCare PCA Infusion System

K143612 is the FDA 510(k) clearance for LifeCare PCA Infusion System by Hospira, Inc.. It is a Class 2 General Hospital device (product code MEA) cleared through the Traditional 510(k) pathway after a 476-day FDA review.

K143612 · Hospira, Inc. · General Hospital
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Apr 2016
Decision
476d
Days
Class 2
Risk

K143612 is an FDA 510(k) clearance for the LifeCare PCA Infusion System. 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 April 8, 2016 after a review of 476 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Hospira, Inc. devices

Submission Details

510(k) Number K143612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2014
Decision Date April 08, 2016
Days to Decision 476 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
347d slower than avg
Panel avg: 129d · This submission: 476d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 10
Devices cleared under the same product code (MEA) and FDA review panel - the closest regulatory comparables to K143612.
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
SYNDEO PCA SYRINGE PUMP, MODEL 2L3113
K031566 · Baxter Healthcare Corp · Aug 2003
STRYKER PAINPUMP2
K030661 · Stryker Instruments · May 2003
ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
K022203 · Abbott Laboratories · Aug 2002