Cleared Traditional

K941692 - FEMALE LENGTH ALL SILICONE UROLOGICAL C...

K941692 is the FDA 510(k) clearance for FEMALE LENGTH ALL SILICONE UROLOGICAL C... by Rochester Medical Corp.. It is a Class 2 Gastroenterology & Urology device (product code EZL) cleared through the Traditional 510(k) pathway after a 334-day FDA review.

K941692 · Rochester Medical Corp. · Gastroenterology & Urology device
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Mar 1995
Decision
334d
Days
Class 2
Risk

K941692 is an FDA 510(k) clearance for the FEMALE LENGTH ALL SILICONE UROLOGICAL 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 March 6, 1995 after a review of 334 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Rochester Medical Corp. devices

Submission Details

510(k) Number K941692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1994
Decision Date March 06, 1995
Days to Decision 334 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
204d slower than avg
Panel avg: 130d · This submission: 334d
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 K941692.
EUROPHILIC SLIPPERY COATED FOLEY CATHETER
K944007 · Baxter Healthcare Corp · Jun 1995
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