Cleared Traditional

KEOFEED 500 ENTERIC FEEDING PUMP (K820063) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K820063 · Hedeco · General Hospital
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Feb 1982
Decision
30d
Days
Class 2
Risk

K820063 is an FDA 510(k) clearance for the KEOFEED 500 ENTERIC FEEDING PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Hedeco (Mchenry, US). The FDA issued a Cleared decision on February 10, 1982 after a review of 30 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 Hedeco devices

Submission Details

510(k) Number K820063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1982
Decision Date February 10, 1982
Days to Decision 30 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 129d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 220
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K820063.
FLEXIFLO-II
K821661 · Abbott Laboratories · Jun 1982
MODEL AS6M INFUSION PUMP
K821069 · Baxter Healthcare Corp · Jun 1982
VOLUMETRIC PUMP CASSETTE W/ATTACHED SET
K820860 · Travenol Laboratories, S.A. · Apr 1982
MODEL AS6B INFUSION PUMP
K813590 · Baxter Healthcare Corp · Jan 1982
5B SLAVE MODULE SYRINGE PUMP
K813473 · Baxter Healthcare Corp · Jan 1982
FLO-GARD 8000 INFUSION PUMP SYSTEM
K813403 · Travenol Laboratories, S.A. · Dec 1981