Cleared Traditional

K844745 - K-TUBE

K844745 is an FDA 510(k) clearance for K-TUBE, manufactured by Midwest Metabolic Support Group. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K844745 · Midwest Metabolic Support Group · Gastroenterology & Urology device
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Jan 1985
Decision
32d
Days
Class 2
Risk

K844745 is an FDA 510(k) clearance for the K-TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Midwest Metabolic Support Group (Chicago, US). The FDA issued a Cleared decision on January 7, 1985 after a review of 32 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.

FDA 510(k) Submission Details - K844745

510(k) Number K844745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1984
Decision Date January 07, 1985
Days to Decision 32 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 131d · This submission: 32d
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 527
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K844745.
IVAC KEOFEED II POLYURETHANE FEEDING TUBE
K850182 · Y · Mar 1985
KANGAROO NASOGASTRIC FEEDING TUBE
K843567 · Chesebrough-Pond'S U.S.A. Co. · Feb 1985
ENTRON ENTERAL FEEDING BAG
K850134 · Biosearch Medical Products, Inc. · Feb 1985
ENTERNAL FEEDING TUBE-POLYURETHANE EF504
K844175 · Exco, Inc. · Jan 1985
ENTERNAL FEEDING TUBE SILICONE-EF401, 402 & 403
K844203 · Exco, Inc. · Jan 1985
KANGAROO ACCESS II ENTERAL FEEDING CONTAINER
K844789 · Chesebrough-Pond'S U.S.A. Co. · Jan 1985