Cleared Traditional

DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR (K071049) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K071049 · Tyco Healthcare · Gastroenterology & Urology device
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Oct 2007
Decision
186d
Days
Class 2
Risk

K071049 is an FDA 510(k) clearance for the DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Tyco Healthcare (Mansfield, US). The FDA issued a Cleared decision on October 16, 2007 after a review of 186 days - an extended review 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: 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 Tyco Healthcare devices

Submission Details

510(k) Number K071049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2007
Decision Date October 16, 2007
Days to Decision 186 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
56d slower than avg
Panel avg: 130d · This submission: 186d
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 127
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K071049.
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