Cleared Traditional

K871728 - MODIFIED LIFECARE 4100 PCA INFUSER

K871728 is an FDA 510(k) clearance for MODIFIED LIFECARE 4100 PCA INFUSER, manufactured by Abbott Laboratories. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K871728 · Abbott Laboratories · General Hospital
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Jul 1987
Decision
83d
Days
Class 2
Risk

K871728 is an FDA 510(k) clearance for the MODIFIED LIFECARE(R) 4100 PCA INFUSER. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on July 27, 1987 after a review of 83 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K871728

510(k) Number K871728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1987
Decision Date July 27, 1987
Days to Decision 83 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 129d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

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 459
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K871728.
ULTRASONIC AIR-IN-LINE DETECTOR (AILD)
K872952 · Imed Corp. · Oct 1987
FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD
K870801 · Travenol Laboratories, S.A. · Sep 1987
RATE INFUSER SYSTEM
K872850 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1987
INFUSION PUMP ENCLOSURE
K872821 · Pharmacia Deltec, Inc. · Jul 1987
NITROGLYCERINE PUMP SET
K871084 · Churchill Corp. · Jul 1987
IMED(R) MODEL 960A VOLUMETRIC INFUSION PUMP
K870991 · Imed Corp. · Jun 1987