Cleared Traditional

K900031 - MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS

K900031 is an FDA 510(k) clearance for MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS, manufactured by Porges Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KNY cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K900031 · Porges Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1990
Decision
61d
Days
Class 2
Risk

K900031 is an FDA 510(k) clearance for the MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Porges Corp. (Gary, US). The FDA issued a Cleared decision on March 6, 1990 after a review of 61 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Porges Corp. devices

FDA 510(k) Submission Details - K900031

510(k) Number K900031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1990
Decision Date March 06, 1990
Days to Decision 61 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
69d faster than avg
Panel avg: 130d · This submission: 61d
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 24
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K900031.
KENDALL CURITY KIDS PEDIATRIC DRAINAGE ADAPTER
K921055 · Kendall Healthcare Products Co. Div.Of Tyco Health · May 1992
MENTOR INFUSION LINE
K912919 · Mentor Corp. · Dec 1991
FLEXI-TRAK(TM) ANCHORING DEVICE
K905128 · Convatec, A Division of E.R. Squibb & Sons · Nov 1990
CATHETER PLUG/PROTECTOR
K896806 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990
TECNOL CATHETER LEG STRAP
K882641 · Tecnol New Jersey Wound Care, Inc. · Jul 1988
DEFLECTING GUIDE WIRE
K833242 · Van-Tec, Inc. · Oct 1983