Cleared Traditional

PVC Hydrophilic Urethral Catheter (K220722) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220722 · Well Lead Medical Co., Ltd. · Gastroenterology & Urology device
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May 2023
Decision
434d
Days
Class 2
Risk

K220722 is an FDA 510(k) clearance for the PVC Hydrophilic Urethral Catheter. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Well Lead Medical Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on May 22, 2023 after a review of 434 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Well Lead Medical Co., Ltd. devices

Submission Details

510(k) Number K220722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2022
Decision Date May 22, 2023
Days to Decision 434 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
304d slower than avg
Panel avg: 130d · This submission: 434d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 42
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K220722.
Cure Catheter Closed System
K230400 · Convatec, Inc. · Nov 2023
Luja Coude (20108 Male CH18 - large packaging)
K233101 · Coloplast Corp. · Oct 2023
Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging)
K230165 · Coloplast · Aug 2023
SimPro™ Now, GentleCath™ Hydrophilic
K223756 · Dentsply Sirona · May 2023
Intermittent nelaton catheter for single use
K222677 · Hangzhou Jimushi Meditech Co., Ltd. · Apr 2023
Sleeved IC
K220667 · Hollister Incorporated · Dec 2022