Cleared Traditional

K921652 - MIC TRANSGASTRIC JEJUNAL FEEDING TUBE KIT

K921652 is the FDA 510(k) clearance for MIC TRANSGASTRIC JEJUNAL FEEDING TUBE KIT by Medical Innovations Corp.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 756-day FDA review.

K921652 · Medical Innovations Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
756d
Days
Class 2
Risk

K921652 is an FDA 510(k) clearance for the MIC TRANSGASTRIC JEJUNAL FEEDING TUBE KIT. 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 May 2, 1994 after a review of 756 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Medical Innovations Corp. devices

Submission Details

510(k) Number K921652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received April 06, 1992
Decision Date May 02, 1994
Days to Decision 756 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
626d slower than avg
Panel avg: 130d · This submission: 756d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 212
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K921652.
ENTEROCLYSIS TUBE
K923002 · Biosearch Medical Products, Inc. · Jun 1994
FLEXIFLO LAPAROSCOPIC JEJUNOSTOMY KIT
K925102 · Abbott Laboratories · Jun 1994
FLEXIFLO GASTROSTOMY KIT
K932861 · Abbott Laboratories · Jun 1994
WILSON-COOK BALLOON INFLATION DEVICE
K936168 · Wilson-Cook Medical, Inc. · Mar 1994
GASTROINTESTINAL FEEDING TUBE
K920703 · Wilson-Cook Medical, Inc. · Dec 1993
HOLLISTER VERTICAL DRAIN/TUBE ATTACHMENT DEVICE
K932855 · Hollister, Inc. · Oct 1993