Cleared Traditional

K931013 - FOLEY CATHETER TRAY

K931013 is an FDA 510(k) clearance for FOLEY CATHETER TRAY, manufactured by Kit Pak, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNY cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K931013 · Kit Pak, Inc. · Gastroenterology & Urology device
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Aug 1993
Decision
164d
Days
Class 2
Risk

K931013 is an FDA 510(k) clearance for the FOLEY CATHETER TRAY. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Kit Pak, Inc. (Elk Grove Village, US). The FDA issued a Cleared decision on August 9, 1993 after a review of 164 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Kit Pak, Inc. devices

FDA 510(k) Submission Details - K931013

510(k) Number K931013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1993
Decision Date August 09, 1993
Days to Decision 164 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
33d slower than avg
Panel avg: 131d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNY Device Classification - Class 2, Special Controls

Product Code KNY Accessories, Catheter, G-u
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - KNY Accessories, Catheter, G-u

All 48
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K931013.
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URINARY CARE SUPPLIES
K923496 · Orion Life Systems, Inc. · May 1993
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K926344 · Surgitek · Mar 1993