Cleared Traditional

K030538 - AMERICAN CATHETER

K030538 is an FDA 510(k) clearance for AMERICAN CATHETER, manufactured by Catheter, LLC. The device is a Class 2 Gastroenterology & Urology device with product code EZD cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K030538 · Catheter, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
18d
Days
Class 2
Risk

K030538 is an FDA 510(k) clearance for the AMERICAN CATHETER, MODEL W3. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Catheter, LLC (Winsted, US). The FDA issued a Cleared decision on March 10, 2003 after a review of 18 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Catheter, LLC devices

FDA 510(k) Submission Details - K030538

510(k) Number K030538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2003
Decision Date March 10, 2003
Days to Decision 18 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 130d · This submission: 18d
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 K030538.
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K973546 · Kendall Healthcare Products Co. Div.Of Tyco Health · Nov 1997
CONVEEN EASICATH SET
K973070 · Coloplast Corp. · Nov 1997