Cleared Traditional

K801725 - KANGAROO ENTERAL FEEDING PUMP

K801725 is the FDA 510(k) clearance for KANGAROO ENTERAL FEEDING PUMP by Chesebrough-Pond'S U.S.A. Co.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K801725 · Chesebrough-Pond'S U.S.A. Co. · General Hospital
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Aug 1980
Decision
20d
Days
Class 2
Risk

K801725 is an FDA 510(k) clearance for the KANGAROO ENTERAL FEEDING PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Chesebrough-Pond'S U.S.A. Co. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1980 after a review of 20 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 Chesebrough-Pond'S U.S.A. Co. devices

Submission Details

510(k) Number K801725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1980
Decision Date August 13, 1980
Days to Decision 20 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
109d faster than avg
Panel avg: 129d · This submission: 20d
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 307
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K801725.
TRAVENOL INFUSION PUMP-2M8016
K802901 · Travenol Laboratories, S.A. · Dec 1980
TRAVENOL 24 HR. INFUSOR (ELASTOMERIC PP)
K802820 · Travenol Laboratories, S.A. · Dec 1980
CORDIS DOW INFUSION PUMP
K802301 · Cordis Corp. · Oct 1980
ABBOTT/SHAW LIFE CARE PUMP MODEL 3
K801441 · Abbott Laboratories · 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