Cleared Traditional

K875126 - MIC (SPECIFIC LINE) INSERTION KIT

K875126 is an FDA 510(k) clearance for MIC (SPECIFIC LINE) INSERTION KIT, 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 78-day FDA review.

K875126 · Medical Innovations Corp. · Gastroenterology & Urology device
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Mar 1988
Decision
78d
Days
Class 2
Risk

K875126 is an FDA 510(k) clearance for the MIC (SPECIFIC LINE) INSERTION 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 March 2, 1988 after a review of 78 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 - K875126

510(k) Number K875126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received December 15, 1987
Decision Date March 02, 1988
Days to Decision 78 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
53d faster than avg
Panel avg: 131d · This submission: 78d
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 K875126.
J-CATH(TM)
K875171 · Hdc Corp. · Apr 1988
ENTERON PERCUTAN. ENDOSCOPIC GASTROSTOMY TRAY-PEG
K873360 · Endovations · Mar 1988
NH REPLACEMENT GASTROSTOMY KIT
K880232 · Biosearch Medical Products, Inc. · Mar 1988
ENTERAL FEEDING TUBE
K874393 · Wilson-Cook Medical, Inc. · Dec 1987
LOW PROFILE GASTROSTOMY
K872771 · Microvasive · Oct 1987
MIC MUSHROOM TIP GASTROSTOMY TUBE
K872531 · Medical Innovations Corp. · Sep 1987