Cleared Traditional

K100366 - MEDICINA ENTERAL FEEDING TUBES AND ACCE...

K100366 is an FDA 510(k) clearance for MEDICINA ENTERAL FEEDING TUBES AND ACCE..., manufactured by Maxter Catheters. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K100366 · Maxter Catheters · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
122d
Days
Class 2
Risk

K100366 is an FDA 510(k) clearance for the MEDICINA ENTERAL FEEDING TUBES AND ACCESSORIES MODEL MGX/YY. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Maxter Catheters (Marseille, FR). The FDA issued a Cleared decision on June 14, 2010 after a review of 122 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Maxter Catheters devices

FDA 510(k) Submission Details - K100366

510(k) Number K100366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2010
Decision Date June 14, 2010
Days to Decision 122 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 130d · This submission: 122d
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 301
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K100366.
PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE
K103254 · Coloplast A/S · Jan 2011
BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM
K102391 · C.R. Bard, Inc. · Dec 2010
PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE
K103109 · C.R. Bard, Inc. · Dec 2010
INSTAFLO BOWEL CATHETER SYSTEM KIT
K100273 · Hollister, Inc. · Apr 2010
COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM
K083770 · Coloplast A/S · Nov 2009
SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND ST-Y0003-H
K091759 · Olympus Medical Systems Corporation · Sep 2009