Cleared Traditional

K173340 - Yikang Latex Foley Catheter

K173340 is an FDA 510(k) clearance for Yikang Latex Foley Catheter, manufactured by Jiangxi Yikang Medical Instrument Group Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code EZL cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K173340 · Jiangxi Yikang Medical Instrument Group Co., Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jul 2018
Decision
263d
Days
Class 2
Risk

K173340 is an FDA 510(k) clearance for the Yikang Latex Foley Catheter. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Jiangxi Yikang Medical Instrument Group Co., Ltd. (Nanchang, CN). The FDA issued a Cleared decision on July 13, 2018 after a review of 263 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 Jiangxi Yikang Medical Instrument Group Co., Ltd. devices

FDA 510(k) Submission Details - K173340

510(k) Number K173340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2017
Decision Date July 13, 2018
Days to Decision 263 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
132d slower than avg
Panel avg: 131d · This submission: 263d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZL Device Classification - Class 2, Special Controls

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 100
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K173340.
AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water
K181814 · Amsino International, Inc. · Sep 2018
Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter
K173657 · Cook Incorporated · Aug 2018
CystoSure Plus Catheter
K181346 · Emmy Medical, LLC · Aug 2018
Silicone Foley Catheter for single use
K172807 · Changzhou Rongxin Medicine Minimal Invasion Technology · Jun 2018
Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter
K173533 · Poiesis Medical, LLC · Mar 2018
Kohli Urinary Drainage Catheter
K172422 · Nellie Medical, LLC · Feb 2018