Cleared Traditional

K911401 - ABBOTT LIFECARE 5000 PUMP

K911401 is an FDA 510(k) clearance for ABBOTT LIFECARE 5000 PUMP, 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 60-day FDA review.

K911401 · Abbott Laboratories · General Hospital
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May 1991
Decision
60d
Days
Class 2
Risk

K911401 is an FDA 510(k) clearance for the ABBOTT LIFECARE 5000 PUMP. 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 May 28, 1991 after a review of 60 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 - K911401

510(k) Number K911401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1991
Decision Date May 28, 1991
Days to Decision 60 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
69d faster than avg
Panel avg: 129d · This submission: 60d
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 K911401.
MODEL 404-SP AND 504-SP INFUSION PUMPS MODIFIED
K912458 · Medtronic Minimed · Jun 1991
RATEMINDER(TM) V INFUSION PUMP, MODIFICATION
K911769 · Critikon Company, LLC · Jun 1991
VOLUMETRIC INFUSION PUMP
K910024 · Baxter Healthcare Corp · May 1991
ABBOTT LIFECARE 5000 PUMP MODIFIED
K910919 · Abbott Laboratories · May 1991
EPIDURAL INDICATION FOR BAXTER SYRINGE INFUS PUMP
K911289 · Baxter Healthcare Corp · May 1991
BARD PCA II PUMP WITH PROGRAM CARTRIDGES
K902613 · C.R. Bard, Inc. · Apr 1991