Cleared Traditional

K922667 - MIC LOW PROFILE GASTROSTOMY TUBE

K922667 is an FDA 510(k) clearance for MIC LOW PROFILE GASTROSTOMY 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 597-day FDA review.

K922667 · Medical Innovations Corp. · Gastroenterology & Urology device
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Dec 1993
Decision
597d
Days
Class 2
Risk

K922667 is an FDA 510(k) clearance for the MIC LOW PROFILE GASTROSTOMY 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 December 1, 1993 after a review of 597 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 - K922667

510(k) Number K922667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received April 13, 1992
Decision Date December 01, 1993
Days to Decision 597 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
466d slower than avg
Panel avg: 131d · This submission: 597d
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 K922667.
MIC PEG TUBE
K924065 · Medical Innovations Corp. · Feb 1994
GASTROINTESTINAL FEEDING TUBE
K920703 · Wilson-Cook Medical, Inc. · Dec 1993
ENFUSE ENTERAL FEEDING TUBE
K922998 · Rusch, Inc. · Dec 1993
INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR
K930456 · Interventional Therapeutics Corp. · Nov 1993
HOLLISTER VERTICAL DRAIN/TUBE ATTACHMENT DEVICE
K932855 · Hollister, Inc. · Oct 1993
FLEXIFLO 60 NASOJEJUNAL FEEDING TUBE
K924996 · Abbott Laboratories · Oct 1993