Cleared Traditional

K853197 - MIC JEJUNAL FEEDING TUBE

K853197 is an FDA 510(k) clearance for MIC JEJUNAL FEEDING 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 23-day FDA review.

K853197 · Medical Innovations Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1985
Decision
23d
Days
Class 2
Risk

K853197 is an FDA 510(k) clearance for the MIC JEJUNAL FEEDING TUBE. 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 22, 1985 after a review of 23 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 - K853197

510(k) Number K853197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1985
Decision Date August 22, 1985
Days to Decision 23 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
108d faster than avg
Panel avg: 131d · This submission: 23d
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 K853197.
E-Z-EM GASTRIC LAVAGE CATHETER
K853384 · E-Z-Em, Inc. · Nov 1985
COONS GASTROSTICK SYSTEM
K852552 · Medi-Tech, Inc. · Oct 1985
FEEDING UNITS & TUBES
K853288 · I M, Inc. · Oct 1985
GASTRO-ENTEROSTOMY TUBE
K852707 · Medical Innovations Corp. · Aug 1985
MIC GASTROSTOMY TUBE PERCUTANEOUS INSERTION KIT
K852363 · Medical Innovations Corp. · Aug 1985
CORPAK ENTERAL SOL ADM PUMP SET W/ SCREW
K852792 · Corpak Co. · Aug 1985