Cleared Traditional

K192034 - HDX 100% Silicone 2-way Foley Catheter

K192034 is the FDA 510(k) clearance for HDX 100% Silicone 2-way Foley Catheter by Pathway, LLC. It is a Class 2 Gastroenterology & Urology device (product code EZL) cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K192034 · Pathway, LLC · Gastroenterology & Urology device
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Apr 2020
Decision
266d
Days
Class 2
Risk

K192034 is an FDA 510(k) clearance for the HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Fo.... Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Pathway, LLC (Santee, US). The FDA issued a Cleared decision on April 21, 2020 after a review of 266 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 Pathway, LLC devices

Submission Details

510(k) Number K192034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2019
Decision Date April 21, 2020
Days to Decision 266 days
Submission Type Traditional
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
136d slower than avg
Panel avg: 130d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZL Catheter, Retention Type, Balloon
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 - EZL Catheter, Retention Type, Balloon

All 58
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K192034.
Well Lead All Silicone Foley Catheter with Temperature Sensor
K202134 · Well Lead Medical Co., Ltd. · Apr 2021
Foley Balloon Catheter for Urology
K201776 · Apollon Co., Ltd. · Dec 2020
Prefilled Syringe
K202698 · Hangzhou Primecare Medical Co., Ltd. · Dec 2020
AquaFlate Pre-Filled Sterile Water Syringe 10mL
K200556 · H R Pharmaceuticals, Inc. · Mar 2020
Silicone Foley Catheter
K182463 · Biosensors International Pte, Ltd. · Nov 2019
Urethrotech UCD
K190060 · Urethrotech · Oct 2019