Cleared Traditional

K854580 - CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH

K854580 is an FDA 510(k) clearance for CONVEEN SELF-SEALING URISHEATH MALE EXT..., manufactured by Coloplast A/S. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K854580 · Coloplast A/S · Gastroenterology & Urology device
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Dec 1985
Decision
28d
Days
Class 2
Risk

K854580 is an FDA 510(k) clearance for the CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Coloplast A/S (Fort Woth, US). The FDA issued a Cleared decision on December 13, 1985 after a review of 28 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 Coloplast A/S devices

FDA 510(k) Submission Details - K854580

510(k) Number K854580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1985
Decision Date December 13, 1985
Days to Decision 28 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 130d · This submission: 28d
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 94
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K854580.
HOLLISTER FEMALE URINARY COLLECTION POUCH
K862934 · Hollister, Inc. · Aug 1986
SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER
K860362 · Travenol Laboratories, S.A. · Apr 1986
AMP CLOSED URINARY DRAINAGE BAG, 1011 & 1011N
K861251 · American Medical Products, Inc. · Apr 1986
URI-CATH SYSTEM
K852490 · Gesco Intl., Inc. · Nov 1985
H-H SEXTON SCUP URINE MGMT. SYS
K853458 · Holter-Hausner Intl. · Aug 1985
KENDALL CURITY URINARY OUTPUT MONITOR DRAINAGE BAG
K852085 · The Kendal Co. · Aug 1985