Cleared Traditional

2-Way 100% Silicone Cleartract Catheter (K222118) - FDA 510(k) Clearance

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

K222118 · Silq Technologies, Corp. · Gastroenterology & Urology device
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Dec 2022
Decision
136d
Days
Class 2
Risk

K222118 is an FDA 510(k) clearance for the 2-Way 100% Silicone Cleartract Catheter. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Silq Technologies, Corp. (Sunny Isles Beach, US). The FDA issued a Cleared decision on December 1, 2022 after a review of 136 days - within the typical 510(k) review window.

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 Silq Technologies, Corp. devices

Submission Details

510(k) Number K222118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2022
Decision Date December 01, 2022
Days to Decision 136 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
6d slower than avg
Panel avg: 130d · This submission: 136d
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 Consultant

Pathway, LLC
Aaron Rogers

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 - EZL Catheter, Retention Type, Balloon

All 42
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K222118.
Teleflex Rusch SoftSimplastic Foley Catheters
K212077 · Teleflexmedical, Inc. · Jul 2023
Flume Catheter
K231101 · Flume Catheter Company, Ltd. · Jun 2023
Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F
K221020 · Potrero Medical, Inc. · Jan 2023
2-Way 100% Silicone ClearTract Catheter
K221625 · Silq Technologies Corporation · Jul 2022
FLUME catheter
K212151 · The Flume Catheter Company, Ltd. · Nov 2021
Well Lead All Silicone Foley Catheter with Temperature Sensor
K202134 · Well Lead Medical Co., Ltd. · Apr 2021