Cleared Traditional

K902684 - MIC ANAL INCONTINENCE TUBE

K902684 is an FDA 510(k) clearance for MIC ANAL INCONTINENCE TUBE, manufactured by Medical Innovations Corp.. 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.

K902684 · Medical Innovations Corp. · Gastroenterology & Urology device
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Sep 1990
Decision
85d
Days
Class 2
Risk

K902684 is an FDA 510(k) clearance for the MIC ANAL INCONTINENCE TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Medical Innovations Corp. (Milpitas, US). The FDA issued a Cleared decision on September 12, 1990 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 Medical Innovations Corp. devices

FDA 510(k) Submission Details - K902684

510(k) Number K902684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1990
Decision Date September 12, 1990
Days to Decision 85 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 131d · 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 416
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K902684.
ENTERAL PUMP SET WITH ENTERAL SPIKE
K895142 · Delmed, Inc. · Oct 1990
600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA
K895329 · Delmed, Inc. · Oct 1990
ENTERAL PUMP SET W/ENTERA-FLO SPIKE
K895650 · Delmed, Inc. · Oct 1990
DOBBHOFF WIRE GUIDED JEJUNAL FEEDING TUBE
K900324 · Biosearch Medical Products, Inc. · Aug 1990
DOBBHOFF(R) ENDOENTERIC GASTRIC DECOMPRESSION CATH
K900563 · Biosearch Medical Products, Inc. · Aug 1990
BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING
K900590 · Biosearch Medical Products, Inc. · Aug 1990