Cleared Traditional

MALE EXTERNAL CATHETER (K820565) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K820565 · Urocare Products, Inc. · Gastroenterology & Urology device
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Apr 1982
Decision
30d
Days
Class 2
Risk

K820565 is an FDA 510(k) clearance for the MALE EXTERNAL CATHETER. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Urocare Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 1, 1982 after a review of 30 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 Urocare Products, Inc. devices

Submission Details

510(k) Number K820565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1982
Decision Date April 01, 1982
Days to Decision 30 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
100d faster than avg
Panel avg: 130d · This submission: 30d
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 19
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K820565.
CLOSED SYS. DRAINAGE BAGS & TRAYS
K832822 · Medline Industries, Inc. · Oct 1983
LEG DRAINAGE BAG STRAP BK6011
K831553 · Fred Sammons, Inc. · Jun 1983
CYSTOFLO URINARY DRAINAGE BAG W/ANTIMIC
K823716 · Travenol Laboratories, S.A. · Jan 1983
ARGYLE PEDIATRIC URINE COLLECTOR
K813479 · Sherwood Medical Co. · Jan 1982
ARGYLE CLOSED URINARY DRAINAGE SET
K802667 · Sherwood Medical Co. · Dec 1980
BARD MALE EXTERNAL CATHETER
K802433 · C.R. Bard, Inc. · Oct 1980