510(k) · Cleared
Cleared2-Way 100% Silicone Cleartract Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Silq Technologies Corporation · EZL Catheter, Retention Type, Balloon
Cleared on Jan 23, 2024 as substantially equivalent to K222118 (Silq Technologies, Corp., 2022) after a 123-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Jan 23, 2024
- Review
- 123 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K984084 (1999). No later device cites it as a predicate yet.
- Root · 4 generations backK984084 Bardex Lubri-Sil Foley CatheterBard Medical Div. · 1999 · Recalled
- 3 generations backK192034 HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone…Pathway, LLC · 2020
- 2 generations backK221625 2-Way 100% Silicone ClearTract CatheterSilq Technologies Corporation · 2022
- 1 generation backK222118 2-Way 100% Silicone Cleartract CatheterSilq Technologies, Corp. · 2022
- This deviceK233013 2-Way 100% Silicone Cleartract CatheterSilq Technologies Corporation · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K984084 | Bardex Lubri-Sil Foley Catheter | Bard Medical Div. | 1999 | 1 |
| −3 | K192034 | HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way… | Pathway, LLC | 2020 | — |
| −2 | K221625 | 2-Way 100% Silicone ClearTract Catheter | Silq Technologies Corporation | 2022 | — |
| −1 | K222118 | 2-Way 100% Silicone Cleartract Catheter | Silq Technologies, Corp. | 2022 | — |
| 0 (this device) | K233013 | 2-Way 100% Silicone Cleartract Catheter | Silq Technologies Corporation | 2024 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EZL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EZL device
- #1 K260756 TraumaGuard Intra-Abdominal Pressure-Sensing…score 13.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K222118 | 2-Way 100% Silicone Cleartract CatheterSummary page 5…ZL Panel: Gastroenterology/Urology 3. PREDICATE AND REFERENCE Predicate: 2-Way 100% Silicone Cleartract Catheter (K222118) DEVICE IDENTIFICATION Reference: Silicone Foley Catheter for single use (K172807) 4. DEVICE DESCRIPTION:… | 2022 |
| † | K172807 | Silicone Foley Catheter for single use | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All EZL devicesEZL Catheter, Retention Type, Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · EZL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EZL
123in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EZL
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · EZL
1,381in 2025
MAUDE reports naming product code EZL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 186 | 0 | 8 |
| 2008 | 2 | — | 0 | 6 |
| 2009 | 4 | 114 | 0 | 6 |
| 2010 | 1 | — | 0 | 27 |
| 2011 | 2 | — | 0 | 79 |
| 2012 | 0 | — | 0 | 65 |
| 2013 | 3 | 151 | 0 | 99 |
| 2014 | 2 | — | 0 | 229 |
| 2015 | 3 | 132 | 0 | 303 |
| 2016 | 1 | — | 0 | 326 |
| 2017 | 2 | — | 0 | 571 |
| 2018 | 9 | 177 | 0 | 677 |
| 2019 | 3 | 266 | 1 | 671 |
| 2020 | 4 | 137 | 0 | 712 |
| 2021 | 2 | — | 0 | 702 |
| 2022 | 2 | — | 0 | 884 |
| 2023 | 3 | 282 | 2 (2) | 772 |
| 2024 | 5 | 123 | 2 | 1,029 |
| 2025 | 1 | — | 0 | 1,381 |
| 2026 | 4 | 170 | 2 | — |
What is it indicated for?
The 2-Way 100% Silicone ClearTract Catheter is intended for drainage of the urinary tract. Catheterization is accomplished by inserting the catheter through the urethra and into the bladder, but also suprapubic placement or by nephrostomy. Intended population is adults and pediatrics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233013 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233013: 2-Way 100% Silicone Cleartract Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233013
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026