510(k) · Cleared
Recalled · Class II · 2024Folysil Silicone Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast Corp. · EZL Catheter, Retention Type, Balloon
Cleared on Apr 15, 2024 as substantially equivalent to K013174 (Porges S.A., 2002) and 1 other predicate after a 192-day review. Its family tree reaches back 1 generation to 1990. It has been recalled once.
- Decided
- Apr 15, 2024
- Review
- 192 days
- Class
- Class II
- Product code
- EZL
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K900031 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK900031 Modified Pediatric Silicone Foley CathetersPorges Corp. · 1990
- This deviceK233411 Folysil Silicone CatheterColoplast Corp. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900031 | Modified Pediatric Silicone Foley Catheters | Porges Corp. | 1990 | — |
| 0 (this device) | K233411 | Folysil Silicone Catheter | Coloplast Corp. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | K013174 | Proges Folysil Silicone Foley Catheter, Straight Cylindrical Tip, Silicone Female Foley…Summary page 5…oon) Panel: Gastroenterology/Urology III. PREDICATE DEVICES IDENTIFICATION Primary Predicate device: Folysil® Silicone Catheter (K013174) Secondary Predicate device: Modified Pediatric Silicone Foley Catheter (K900031)… | 2002 |
| * | K900031 | Modified Pediatric Silicone Foley CathetersSummary page 5…VICES IDENTIFICATION Primary Predicate device: Folysil® Silicone Catheter (K013174) Secondary Predicate device: Modified Pediatric Silicone Foley Catheter (K900031) Page 2.03-1… | 1990 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 2, 2024 | Class II | Z-0844-2025 | Packaging | A possible sterility issue was detected in Coloplast's facility on some Coloplast products. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
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?
Folysil catheters are intended for use up to 30 days in adult and pediatric populations for:
- Bladder drainage by urethral catheterization,
- Bladder drainage by suprapubic catheterization for catheter replacement only (for non-grooved, straight 2-way Folysil catheters with a maximum balloon volume of 15mL).
- Bladder instillation of physiological saline solution.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233411 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233411: Folysil Silicone Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233411
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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