Cleared Traditional

K931921 - CORPAK GASTROSTOMY TUBE

K931921 is the FDA 510(k) clearance for CORPAK GASTROSTOMY TUBE by Corpak Co.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 784-day FDA review.

K931921 · Corpak Co. · Gastroenterology & Urology device
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Jun 1995
Decision
784d
Days
Class 2
Risk

K931921 is an FDA 510(k) clearance for the CORPAK GASTROSTOMY TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Corpak Co. (Wheeling, US). The FDA issued a Cleared decision on June 9, 1995 after a review of 784 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Corpak Co. devices

Submission Details

510(k) Number K931921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1993
Decision Date June 09, 1995
Days to Decision 784 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
654d slower than avg
Panel avg: 130d · This submission: 784d
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 K931921.
REPLACEMENT GASTROSTOMY FEEDING CATHETER TRAY
K954776 · United States Endoscopy Group, Inc. · Jan 1996
BARD(R) JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBES
K946249 · C.R. Bard, Inc. · Dec 1995
HOLLISTER NASOGASTRIC TUBE ATTACHMENT DEVICE
K953232 · Hollister, Inc. · Aug 1995
PERCUTANEOUS ENDOSCOPIC GASTROSTOMY
K924306 · United States Endoscopy Group, Inc. · May 1995
FLEXIFLO SIX ENTERAL NUTRITION PUMP SET
K943240 · Abbott Laboratories · Apr 1995
FLEXIFLO NASOENTERIC FEEDING TUBE
K922217 · Abbott Laboratories · Mar 1995