Cleared Special

K180738 - COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter (FDA 510(k) Clearance)

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

K180738 · Compactcath, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
84d
Days
Class 2
Risk

K180738 is an FDA 510(k) clearance for the COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent .... Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Compactcath, Inc. (Palo Alto, US). The FDA issued a Cleared decision on June 14, 2018 after a review of 84 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Compactcath, Inc. devices

Submission Details

510(k) Number K180738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2018
Decision Date June 14, 2018
Days to Decision 84 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 130d · This submission: 84d
Pathway characteristics
Modification to existing cleared device.

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 80
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K180738.
LoFric Elle Pro
K260999 · Wellspect AB · Apr 2026
GentleCath Air for Men
K252943 · Convatec Limited · Apr 2026
Liv Pre-lubricated Intermittent Catheter
K260502 · HR Healthcare · Mar 2026
EZ-Protect Hydrophilic Closed System Intermittent Catheter
K251274 · HR Healthcare · Jan 2026
Ready to use Nelaton Catheter
K251178 · Jamjoom Fullcare Corporation · Jan 2026
Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A)
K251468 · Hollister Incorporated · Oct 2025