Cleared Traditional

K791528 - FLEXIFO ENTERAL NUTRITION PUMP

K791528 is an FDA 510(k) clearance for FLEXIFO ENTERAL NUTRITION 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 33-day FDA review.

K791528 · Abbott Laboratories · General Hospital
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Sep 1979
Decision
33d
Days
Class 2
Risk

K791528 is an FDA 510(k) clearance for the FLEXIFO ENTERAL NUTRITION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Abbott Laboratories (Mchenry, US). The FDA issued a Cleared decision on September 12, 1979 after a review of 33 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 - K791528

510(k) Number K791528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1979
Decision Date September 12, 1979
Days to Decision 33 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
96d faster than avg
Panel avg: 129d · This submission: 33d
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 K791528.
HEPARIN PUMP #7420
K800570 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1980
3M SMALL VOLUME INFUSTION (SVI) SYSTEM
K792050 · 3M Company · Mar 1980
MODEL IV 6500 FORMULATOR
K792142 · Valleylab, Inc. · Nov 1979
ALARM
K790559 · Maddak, Inc. · Jun 1979
BLOOD CELL SEPARATOR SYSTEM CS3000
K790315 · Travenol Laboratories, S.A. · May 1979
MODEL IV6000 INFUSION PUMP
K790332 · Valleylab, Inc. · Apr 1979