Cleared Special

COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter (K180738) - 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
Combination Product No
PCCP Authorized No
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 Consultant

Atom Health Corporation
Tehyen Chu

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EZD Catheter, Straight

All 42
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K180738.
LoFric Elle
K211212 · Dentsply Sirona · Feb 2022
Wiygul Catheter
K202566 · Big Blue Biotech, Inc. · Sep 2020
AMSure Hydrophilic Intermittent Catheter
K181445 · Amsino International, Inc. · Oct 2018
Medline Catheter Specimen Collector
K172541 · Medline Industries, Inc. · Feb 2018
Magic3 Go Intermittent Urinary Catheter
K172247 · C.R. Bard, Inc. · Sep 2017
Magic3 Go Intermittent Urinary Catheter
K150345 · C.R. Bard, Inc. · May 2015