Cleared Abbreviated

EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER (K041416) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K041416 · Deroyal · Gastroenterology & Urology device
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Jul 2004
Decision
36d
Days
Class 2
Risk

K041416 is an FDA 510(k) clearance for the EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER. Classified as Catheter, Upper Urinary Tract (product code EYC), Class II - Special Controls.

Submitted by Deroyal (Powell, US). The FDA issued a Cleared decision on July 2, 2004 after a review of 36 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Deroyal devices

Submission Details

510(k) Number K041416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2004
Decision Date July 02, 2004
Days to Decision 36 days
Submission Type Abbreviated
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 130d · This submission: 36d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code EYC Catheter, Upper Urinary Tract
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.