Cleared Traditional

K921370 - MIC GASTRO-ENTEROSTOMY TUBE MODIFICATION

K921370 is an FDA 510(k) clearance for MIC GASTRO-ENTEROSTOMY TUBE MODIFICATION, 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 773-day FDA review.

K921370 · Medical Innovations Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
773d
Days
Class 2
Risk

K921370 is an FDA 510(k) clearance for the MIC GASTRO-ENTEROSTOMY TUBE MODIFICATION. 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 773 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

FDA 510(k) Submission Details - K921370

510(k) Number K921370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received March 20, 1992
Decision Date May 02, 1994
Days to Decision 773 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
642d slower than avg
Panel avg: 131d · This submission: 773d
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 K921370.
FLEXIFLO LAPAROSCOPIC JEJUNOSTOMY KIT
K925102 · Abbott Laboratories · Jun 1994
FLEXIFLO GASTROSTOMY KIT
K932861 · Abbott Laboratories · Jun 1994
E-Z PEG
K921680 · Mill-Rose Laboratory · May 1994
MIC TRANSGASTRIC JEJUNAL FEEDING TUBE KIT
K921652 · Medical Innovations Corp. · May 1994
VYGON - ENTERAL FEEDING TUBE - POLYURETHANE
K925854 · Vygon Corp. · May 1994
WILSON-COOK BALLOON INFLATION DEVICE
K936168 · Wilson-Cook Medical, Inc. · Mar 1994