Cleared Traditional

K852965 - ENTERAL FEEDING PUMP

K852965 is the FDA 510(k) clearance for ENTERAL FEEDING PUMP by Empire Industries, Inc.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K852965 · Empire Industries, Inc. · General Hospital
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Aug 1985
Decision
40d
Days
Class 2
Risk

K852965 is an FDA 510(k) clearance for the ENTERAL FEEDING PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Empire Industries, Inc. (North Attleboro, US). The FDA issued a Cleared decision on August 21, 1985 after a review of 40 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 Empire Industries, Inc. devices

Submission Details

510(k) Number K852965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1985
Decision Date August 21, 1985
Days to Decision 40 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
89d faster than avg
Panel avg: 129d · This submission: 40d
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 385
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K852965.
MP0400 ADULT, PERISTALIC INFUSION PUMP
K853814 · Medex, Inc. · Jan 1986
THE TRAVENOL 5 ML/HR INFUSOR
K853881 · Travenol Laboratories, S.A. · Dec 1985
TRAVENOL MULTIDAY INFUSOR 2C1080
K842905 · Travenol Laboratories, S.A. · Nov 1985
SYRINGE INFUSION PUMP - AS 20 SERIES
K852358 · Baxter Healthcare Corp · Jul 1985
INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123
K852060 · Cardiac Pacemakers, Inc. · Jun 1985
VIAL SYRINGE PUMPS, SE200, SE200B & SE400
K852073 · Hospal Medical Corp. · Jun 1985