Cleared Traditional

COMPACTCATH INTERMITTENT URINARY CATHETER (K140945) - FDA 510(k) Clearance

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

K140945 · Compactcath, Inc. · Gastroenterology & Urology device
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Aug 2014
Decision
130d
Days
Class 2
Risk

K140945 is an FDA 510(k) clearance for the COMPACTCATH INTERMITTENT URINARY CATHETER. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Compactcath, Inc. (Lutsen, US). The FDA issued a Cleared decision on August 22, 2014 after a review of 130 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 Compactcath, Inc. devices

Submission Details

510(k) Number K140945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2014
Decision Date August 22, 2014
Days to Decision 130 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
At panel average
Panel avg: 130d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 43
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K140945.
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Bard RiteCath Intermittent Urinary Catheter
K142575 · C.R. Bard, Inc. · Oct 2014
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K133470 · C.R. Bard, Inc. · Apr 2014
COMFORTGLIDE INTERMITENT CATHETER
K112137 · C.R. Bard, Inc. · Aug 2011
MEDLINE PVC URETHRAL CATHETER
K100302 · Medline Industries, Inc. · Jul 2010