Cleared Traditional

K833687 - DISPOS. ENTERIC FEEDING TUBES W/SAFE-T

K833687 is the FDA 510(k) clearance for DISPOS. ENTERIC FEEDING TUBES W/SAFE-T by Superior Plastic Products Corp.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K833687 · Superior Plastic Products Corp. · Gastroenterology & Urology device
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Mar 1984
Decision
123d
Days
Class 2
Risk

K833687 is an FDA 510(k) clearance for the DISPOS. ENTERIC FEEDING TUBES W/SAFE-T. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Superior Plastic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on March 2, 1984 after a review of 123 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 Superior Plastic Products Corp. devices

Submission Details

510(k) Number K833687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1983
Decision Date March 02, 1984
Days to Decision 123 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
7d faster than avg
Panel avg: 130d · This submission: 123d
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 209
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K833687.
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
NEEDLE CATHETER JEJUNOSTOMY KIT
K833513 · Biosearch Medical Products, Inc. · Nov 1983
ENTRI FLEX FEEDING TUBE
K833621 · Biosearch Medical Products, Inc. · Nov 1983