Cleared Traditional

K871019 - ENFUSE ENTERNAL ADMINISTRATION SET & PU...

K871019 is an FDA 510(k) clearance for ENFUSE ENTERNAL ADMINISTRATION SET & PU..., manufactured by Entech, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K871019 · Entech, Inc. · Gastroenterology & Urology device
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Jun 1987
Decision
85d
Days
Class 2
Risk

K871019 is an FDA 510(k) clearance for the ENFUSE ENTERNAL ADMINISTRATION SET & PUMP SET. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Entech, Inc. (Lebanon, US). The FDA issued a Cleared decision on June 9, 1987 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology 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

FDA 510(k) Submission Details - K871019

510(k) Number K871019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1987
Decision Date June 09, 1987
Days to Decision 85 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 130d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNT Device Classification - Class 2, Special Controls

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNT Tubes, Gastrointestinal (and Accessories)

All 302
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K871019.
ENTERAL FEEDING TUBE
K874393 · Wilson-Cook Medical, Inc. · Dec 1987
FLEXIFLO TOPTAINER TOP-FILL ENTERAL NUTRIT. SYSTEM
K871846 · Abbott Laboratories · Aug 1987
ENTRIMIT GRAVITY FEEDING SET
K871528 · Biosearch Medical Products, Inc. · Aug 1987
ENTERAL ADMINISTRATION ADAPTERS
K864182 · Biosearch Medical Products, Inc. · Dec 1986
CRAIG NASO-GASTRIC TUBE HOLDER
K862855 · Henley Intl. · Nov 1986
T-FASTENER
K861599 · Medi-Tech, Inc. · Oct 1986