Cleared Traditional

K894506 - ENTERA-FLO ENTERAL FEEDING PUMP

K894506 is the FDA 510(k) clearance for ENTERA-FLO ENTERAL FEEDING PUMP by Delmed, Inc.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 383-day FDA review.

K894506 · Delmed, Inc. · General Hospital
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Aug 1990
Decision
383d
Days
Class 2
Risk

K894506 is an FDA 510(k) clearance for the ENTERA-FLO ENTERAL FEEDING PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Delmed, Inc. (New Brunswick, US). The FDA issued a Cleared decision on August 6, 1990 after a review of 383 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Delmed, Inc. devices

Submission Details

510(k) Number K894506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1989
Decision Date August 06, 1990
Days to Decision 383 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
254d slower than avg
Panel avg: 129d · This submission: 383d
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 306
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K894506.
AMBULATORY INFUSER AND ASSOC. FLOW CONTROLLING SET
K902432 · Abbott Laboratories · Sep 1990
LIFECARE MODEL 4 PUMP
K900467 · Abbott Laboratories · Aug 1990
LIFECARE(R) MODEL 3 PUMP
K900468 · Abbott Laboratories · Aug 1990
BECTON DICKINSON PROGRAM 2 INFUSION PUMP
K900375 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990
BECTON DICKINSON 360 INFUSER (TM) SYSTEM
K902409 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1990
ABBOTT LIFECARE 4100 PCA INFUSER
K895710 · Abbott Laboratories · Jul 1990