Cleared Traditional

K832450 - URO-TEX MALE EXTERNAL CATHETER

K832450 is an FDA 510(k) clearance for URO-TEX MALE EXTERNAL CATHETER, manufactured by Sierra Laboratories, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K832450 · Sierra Laboratories, Inc. · Gastroenterology & Urology device
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Oct 1983
Decision
80d
Days
Class 2
Risk

K832450 is an FDA 510(k) clearance for the URO-TEX MALE EXTERNAL CATHETER. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Sierra Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 14, 1983 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5250 - 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 Sierra Laboratories, Inc. devices

FDA 510(k) Submission Details - K832450

510(k) Number K832450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1983
Decision Date October 14, 1983
Days to Decision 80 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
51d faster than avg
Panel avg: 131d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNX Device Classification - Class 2, Special Controls

Product Code KNX Collector, Urine, (and Accessories) For Indwelling Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5250
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 - KNX Collector, Urine, (and Accessories) For Indwelling Catheter

All 103
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K832450.
URETHRAL CATH. TRAY W/BAG
K840292 · Corpak Co. · Mar 1984
URIHESIVE SYSTEM - IMPROVED
K834337 · Convatec, A Division of E.R. Squibb & Sons · Feb 1984
COLOPLAST BABY URINE COLLECTORS
K833570 · Coloplast A/S · Jan 1984
CLOSED SYS. DRAINAGE BAGS & TRAYS
K832822 · Medline Industries, Inc. · Oct 1983
URINE BAG SYSTEM
K831796 · I M, Inc. · Aug 1983
LEG DRAINAGE BAG STRAP BK6011
K831553 · Fred Sammons, Inc. · Jun 1983