Cleared Traditional

K841224 - URO-MALE INCONTINENCE CATHETER

K841224 is the FDA 510(k) clearance for URO-MALE INCONTINENCE CATHETER by Gil-Med Industries C/O Kegan & Kegan, Ltd.. It is a Class 2 Gastroenterology & Urology device (product code KNX) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K841224 · Gil-Med Industries C/O Kegan & Kegan, Ltd. · Gastroenterology & Urology device
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May 1984
Decision
41d
Days
Class 2
Risk

K841224 is an FDA 510(k) clearance for the URO-MALE INCONTINENCE CATHETER. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Gil-Med Industries C/O Kegan & Kegan, Ltd. (Mchenry, US). The FDA issued a Cleared decision on May 2, 1984 after a review of 41 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 Gil-Med Industries C/O Kegan & Kegan, Ltd. devices

Submission Details

510(k) Number K841224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1984
Decision Date May 02, 1984
Days to Decision 41 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
89d faster than avg
Panel avg: 130d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 76
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K841224.
CHESEBROUGH-POND'S REUSABLE URINARY LEG
K842553 · Chesebrough-Pond'S U.S.A. Co. · Jul 1984
CYSTO-AID
K841197 · E-Z-Em, Inc. · Jul 1984
CURITY RIG FOLEY CATH TRAY
K841169 · The Kendal Co. · Jul 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