Cleared Traditional

K852363 - MIC GASTROSTOMY TUBE PERCUTANEOUS INSERTION KIT

K852363 is an FDA 510(k) clearance for MIC GASTROSTOMY TUBE PERCUTANEOUS INSER..., 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 66-day FDA review.

K852363 · Medical Innovations Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1985
Decision
66d
Days
Class 2
Risk

K852363 is an FDA 510(k) clearance for the MIC GASTROSTOMY TUBE PERCUTANEOUS INSERTION KIT. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Medical Innovations Corp. (San Jose, US). The FDA issued a Cleared decision on August 9, 1985 after a review of 66 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 - K852363

510(k) Number K852363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1985
Decision Date August 09, 1985
Days to Decision 66 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
65d faster than avg
Panel avg: 131d · This submission: 66d
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 K852363.
FEEDING UNITS & TUBES
K853288 · I M, Inc. · Oct 1985
MIC JEJUNAL FEEDING TUBE
K853197 · Medical Innovations Corp. · Aug 1985
GASTRO-ENTEROSTOMY TUBE
K852707 · Medical Innovations Corp. · Aug 1985
CORPAK ENTERAL SOL ADM PUMP SET W/ SCREW
K852792 · Corpak Co. · Aug 1985
ENDO-TUBE
K850664 · Biosearch Medical Products, Inc. · Jun 1985
GASTROINTESTINAL TUBE
K851671 · Sheridan Catheter Corp. · Jun 1985