Cleared Traditional

K220036 - Wellead Ureteral Catheter

K220036 is an FDA 510(k) clearance for Wellead Ureteral Catheter, manufactured by Well Lead Medical Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 345-day FDA review.

K220036 · Well Lead Medical Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2022
Decision
345d
Days
Class 2
Risk

K220036 is an FDA 510(k) clearance for the Wellead Ureteral Catheter. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Well Lead Medical Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on December 16, 2022 after a review of 345 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Well Lead Medical Co., Ltd. devices

FDA 510(k) Submission Details - K220036

510(k) Number K220036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2022
Decision Date December 16, 2022
Days to Decision 345 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
215d slower than avg
Panel avg: 130d · This submission: 345d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOD Device Classification - Class 2, Special Controls

Product Code KOD Catheter, Urological
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 - KOD Catheter, Urological

All 136
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K220036.
Rubber Utility Catheter
K251864 · C.R. Bard, Inc. · Feb 2026
allFlex Ureteral Catheters, Krait Ureteral Catheters
K220730 · Allwin Medical Devices, Inc. · Oct 2022
Urinary Catheter 12 Fr, Urinary Catheter 16 Fr
K211032 · Urogen Pharma, Ltd. · Nov 2021
Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter
K181979 · Teleflexmedical, Inc. · May 2019
UroGen Ureteral Catheter
K180354 · Urogen Pharma, Ltd. · Oct 2018
Angled Tip Ureteral Catheter
K181144 · Cook Incorporated · Jun 2018