Cleared Traditional

K854660 - THE MMG ENTERAL FEEDING ADMINISTRATION SET

K854660 is an FDA 510(k) clearance for THE MMG ENTERAL FEEDING ADMINISTRATION SET, manufactured by Medical Technologies of Georgia. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K854660 · Medical Technologies of Georgia · Gastroenterology & Urology device
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Jan 1986
Decision
62d
Days
Class 2
Risk

K854660 is an FDA 510(k) clearance for the THE MMG ENTERAL FEEDING ADMINISTRATION SET. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Medical Technologies of Georgia (Wilbraham, US). The FDA issued a Cleared decision on January 21, 1986 after a review of 62 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 Medical Technologies of Georgia devices

FDA 510(k) Submission Details - K854660

510(k) Number K854660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1985
Decision Date January 21, 1986
Days to Decision 62 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
69d faster than avg
Panel avg: 131d · This submission: 62d
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 429
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K854660.
XRO GASTRO-DUODENAL, DUAL FLOW TUBE, SALEM TYPE
K860285 · Vygon Corp. · Feb 1986
ENTERAL FEEDING BAG
K854616 · Medovations, Inc. · Jan 1986
DYNAFEED ENTERAL PUMP FEED BAG
K860075 · Medline Industries, Inc. · Jan 1986
COLOSHIELD KIT
K855121 · Deknatel, Inc. · Jan 1986
DYNAFEED
K854215 · Medline Industries, Inc. · Dec 1985
CORPAK FARRELL VALVE ENTERAL GASTRIC PRESSURE RELI
K853253 · Corpak Co. · Nov 1985