Cleared Traditional

K841428 - JEJUNOSTOMY SET FOR TUBE FEEDING

K841428 is the FDA 510(k) clearance for JEJUNOSTOMY SET FOR TUBE FEEDING by Burron Medical Products, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K841428 · Burron Medical Products, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1984
Decision
94d
Days
Class 2
Risk

K841428 is an FDA 510(k) clearance for the JEJUNOSTOMY SET FOR TUBE FEEDING. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Burron Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 9, 1984 after a review of 94 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 Burron Medical Products, Inc. devices

Submission Details

510(k) Number K841428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1984
Decision Date July 09, 1984
Days to Decision 94 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
36d faster than avg
Panel avg: 130d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 208
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K841428.
BIOSEARCH GLASER PEG PERCUTANEOUS ENDOSCOPIC GASTR
K844222 · Biosearch Medical Products, Inc. · Dec 1984
DAVOL GAUDERER-PONSKY PERCUTAN-ENDOSCOP
K843305 · C.R. Bard, Inc. · Oct 1984
IVAC KEOFEED HYDROPHILIC FEEDING TUBE
K842589 · Y · Aug 1984
GORE-TEX CATHETER
K840864 · W.L. Gore & Associates, Inc. · Jun 1984
NEEDLE CATHETER JEJUNOSTOMY REPAIR KIT
K840936 · Biosearch Medical Products, Inc. · Mar 1984
ISLAMI GASTROINTESTINAL TUBE
K834268 · Biosearch Medical Products, Inc. · Feb 1984