Cleared Traditional

K801441 - ABBOTT/SHAW LIFE CARE PUMP MODEL 3

K801441 is an FDA 510(k) clearance for ABBOTT/SHAW LIFE CARE PUMP MODEL 3, 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 53-day FDA review.

K801441 · Abbott Laboratories · General Hospital
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Aug 1980
Decision
53d
Days
Class 2
Risk

K801441 is an FDA 510(k) clearance for the ABBOTT/SHAW LIFE CARE PUMP MODEL 3. 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 August 12, 1980 after a review of 53 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 - K801441

510(k) Number K801441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1980
Decision Date August 12, 1980
Days to Decision 53 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
76d faster than avg
Panel avg: 129d · This submission: 53d
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 K801441.
THE SIMPLICITY PUMP #2100 INFUSION PUMP
K801546 · Critikon Company, LLC · Aug 1980
OPEN-LOOP INSULIN DELIVERY SYSTEM
K801704 · Delta Medical Industries · Aug 1980
KANGAROO ENTERAL FEEDING PUMP
K801725 · Chesebrough-Pond'S U.S.A. Co. · Aug 1980
AMBULATORY INFUSION PUMP, CODE 2M9807
K800627 · Travenol Laboratories, S.A. · Jul 1980
INTRAVENOUS INFUSION PUMP, CODE 2M8015
K800629 · Travenol Laboratories, S.A. · May 1980
HEPARIN PUMP #7420
K800570 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1980