Cleared Traditional

K905042 - COMFORT SLEEVED ALL SILICONE FOLEY CATH...

K905042 is the FDA 510(k) clearance for COMFORT SLEEVED ALL SILICONE FOLEY CATH... by Rochester Medical Corp.. It is a Class 2 Gastroenterology & Urology device (product code EZL) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K905042 · Rochester Medical Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1991
Decision
72d
Days
Class 2
Risk

K905042 is an FDA 510(k) clearance for the COMFORT SLEEVED ALL SILICONE FOLEY CATHETER. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Rochester Medical Corp. (Stewartville, US). The FDA issued a Cleared decision on January 18, 1991 after a review of 72 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 Rochester Medical Corp. devices

Submission Details

510(k) Number K905042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1990
Decision Date January 18, 1991
Days to Decision 72 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
58d faster than avg
Panel avg: 130d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZL Catheter, Retention Type, Balloon
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 - EZL Catheter, Retention Type, Balloon

All 52
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K905042.
SILICONE FOLEY CATHETER
K951106 · Cook Urological, Inc. · May 1995
SILASTIC BRAND FOLEY CATHETER
K951103 · C.R. Bard, Inc. · Apr 1995
SILICONE FOLEY CATHETER
K930344 · Cook Urological, Inc. · Apr 1994
WRP FOLEYCATH
K903777 · Wembley Rubber Products (M) Sdn Bhd · Dec 1990
CURITY 100% SILICONE IRRIGATION FOLEY
K810691 · The Kendal Co. · Mar 1981