Cleared Special

2-Way 100% Silicone ClearTract Catheter (K221625) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K221625 · Silq Technologies Corporation · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jul 2022
Decision
25d
Days
Class 2
Risk

K221625 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 Corporation (Sunny Isles Beach, US). The FDA issued a Cleared decision on July 1, 2022 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Silq Technologies Corporation devices

Submission Details

510(k) Number K221625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2022
Decision Date July 01, 2022
Days to Decision 25 days
Submission Type Special
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
105d faster than avg
Panel avg: 130d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 42
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K221625.
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
K222118 · Silq Technologies, Corp. · Dec 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
Foley Balloon Catheter for Urology
K201776 · Apollon Co., Ltd. · Dec 2020