Cleared Traditional

K260919 - Transurethral Catheter Safety Valve (TUCSV) (80050)

K260919 is an FDA 510(k) clearance for Transurethral Catheter Safety Valve (TU..., manufactured by Class Medical , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KNY cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K260919 · Class Medical , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
139d
Days
Class 2
Risk

K260919 is an FDA 510(k) clearance for the Transurethral Catheter Safety Valve (TUCSV) (80050). Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Class Medical , Ltd. (Co Limerick, IE). The FDA issued a Cleared decision on August 5, 2026 after a review of 139 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Class Medical , Ltd. devices

FDA 510(k) Submission Details - K260919

510(k) Number K260919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2026
Decision Date August 05, 2026
Days to Decision 139 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 131d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNY Device Classification - Class 2, Special Controls

Product Code KNY Accessories, Catheter, G-u
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 Consultant

RQM+
David Worrell

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KNY Accessories, Catheter, G-u

All 41
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K260919.
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BI-FLEX URETERAL ACCESS SHEATH
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WIJAY EZ-VOID EXTERNAL CATHETER VALVE
K140562 · Leomed, LLC · Jun 2014
GUARDIAN URETHRAL SHEATH
K141252 · Solace Therapeutics · Jun 2014
GUARDIAN URETHRAL SHEATH
K131803 · Solace Therapeutics · Aug 2013