Cleared Traditional

K090576 - FOOTPRINT URINARY DRAINAGE CATHETER

K090576 is an FDA 510(k) clearance for FOOTPRINT URINARY DRAINAGE CATHETER, manufactured by Footprint Medical. The device is a Class 2 Gastroenterology & Urology device with product code EZD cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K090576 · Footprint Medical · Gastroenterology & Urology device
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Aug 2009
Decision
162d
Days
Class 2
Risk

K090576 is an FDA 510(k) clearance for the FOOTPRINT URINARY DRAINAGE CATHETER. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Footprint Medical (San Antonio, US). The FDA issued a Cleared decision on August 12, 2009 after a review of 162 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 Footprint Medical devices

FDA 510(k) Submission Details - K090576

510(k) Number K090576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2009
Decision Date August 12, 2009
Days to Decision 162 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
32d slower than avg
Panel avg: 130d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZD Device Classification - Class 2, Special Controls

Product Code EZD Catheter, Straight
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 - EZD Catheter, Straight

All 50
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K090576.
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K050008 · Mentor Corp. · Jun 2005
KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER
K973546 · Kendall Healthcare Products Co. Div.Of Tyco Health · Nov 1997