Cleared Traditional

ENTECH ENTERAL PUMP AND SET (K873444) - FDA 510(k) Clearance

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

K873444 · Entech, Inc. · General Hospital
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Nov 1987
Decision
67d
Days
Class 2
Risk

K873444 is an FDA 510(k) clearance for the ENTECH ENTERAL PUMP AND SET. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Entech, Inc. (Lebanon, US). The FDA issued a Cleared decision on November 2, 1987 after a review of 67 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 Entech, Inc. devices

Submission Details

510(k) Number K873444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1987
Decision Date November 02, 1987
Days to Decision 67 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
62d faster than avg
Panel avg: 129d · This submission: 67d
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 221
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K873444.
BARD AMBULATORY PCA DRUG DELIVERY SYSTEM
K873522 · C.R. Bard, Inc. · Dec 1987
BARD MICROINFUSER I INSULIN INFUSION PUMP
K871807 · C.R. Bard, Inc. · Dec 1987
CORMED III AMBULATORY INFUSION PUMP
K873847 · C.R. Bard, Inc. · Dec 1987
FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD
K870801 · Travenol Laboratories, S.A. · Sep 1987
RATE INFUSER SYSTEM
K872850 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1987
MODIFIED LIFECARE(R) 4100 PCA INFUSER
K871728 · Abbott Laboratories · Jul 1987