Cleared Traditional

K925281 - KIT PAK URINARY CARE SUPPLIES

K925281 is an FDA 510(k) clearance for KIT PAK URINARY CARE SUPPLIES, 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 181-day FDA review.

K925281 · Kit Pak, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
181d
Days
Class 2
Risk

K925281 is an FDA 510(k) clearance for the KIT PAK URINARY CARE SUPPLIES. 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 April 19, 1993 after a review of 181 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 - K925281

510(k) Number K925281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received October 20, 1992
Decision Date April 19, 1993
Days to Decision 181 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
50d slower than avg
Panel avg: 131d · This submission: 181d
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 K925281.
FLEXI-TRAK ANCHORING DEVICE
K932143 · Convatec, A Division of E.R. Squibb & Sons · Dec 1993
NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO
K925161 · North American Sterilization & Packaging Co. · Jul 1993
URINARY CARE SUPPLIES
K923496 · Orion Life Systems, Inc. · May 1993
HYDROPHILIC COATED GUIDEWIRE
K926344 · Surgitek · Mar 1993
GUIDEWIRE
K921200 · Lake Region Mfg., Inc. · Sep 1992
KENDALL CURITY KIDS PEDIATRIC DRAINAGE ADAPTER
K921055 · Kendall Healthcare Products Co. Div.Of Tyco Health · May 1992