510(k) · Cleared
ClearedPercucath Urinary Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Percuvision, LLC · EZL Catheter, Retention Type, Balloon
Cleared on May 28, 2009 as substantially equivalent to K002868 (C.R. Bard, Inc., 2000) and 1 other predicate after a 114-day review. Its family tree reaches back 1 generation to 1986. 1 of the 4 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- May 28, 2009
- Review
- 114 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K860484 (1986). 2 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK860484 Curity & Kenguard Silicone Coated Foley CatheterThe Kendal Co. · 1986 · Recalled (Class I)
- This deviceK090262 Percucath Urinary CatheterPercuvision, LLC · 2009
- Descendant · cites it directly · 0 of its ownK110214 Directvision Catheter, UncoatedPercuvision · 2011
Class I recalls in this family
- K860484 Curity & Kenguard Silicone Coated Foley Catheterdirect predicate · 1986
Most influential descendants
Showing 1 of 1 · See all- K110214Directvision Catheter, UncoatedPercuvision · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K860484 | Curity & Kenguard Silicone Coated Foley Catheter | The Kendal Co. | 1986 | Class I |
| 0 (this device) | K090262 | Percucath Urinary Catheter | Percuvision, LLC | 2009 | — |
| +1 | K110214 | Directvision Catheter, Uncoated | Percuvision | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K002868 | Bard All-Silicone 3-Way Foley Catheter; Bard Lubri-Sil 3-Way Foley Catheter; Bard…Summary page 1…rcuCathTm Urinary Catheter is substantially equivalent t6 the Bardex® Lubri-Sil® 3-Way Foley Catheter marketed by C.R. Bard, Inc., 5 10(k) Premarket Notification Number: K002868 FDA Product Code EZL. Secondly, it is substantially equivalent to the Doverg 100% Silicone Foley Council Tip Catheter with manufa… | 2000 |
| * | K860484 | Curity & Kenguard Silicone Coated Foley CatheterSummary page 1…ondly, it is substantially equivalent to the Doverg 100% Silicone Foley Council Tip Catheter with manufactured by Tyco Healthcare, 5 10(k) Premarket Notification Number: K860484, FDA Product Code KOD. General Description The PercuCathTM Urinary Catheter is a flexible tubular device that is inserted throu… | 1986 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110214 | Directvision Catheter, Uncoated | 2011 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K860484Curity & Kenguard Silicone Coated Foley CatheterThe Kendal Co. · 1986 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All EZL devicesEZL Catheter, Retention Type, Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 PercuCathTM Catheter is indicated for use in the drainage and/or collection and/or measurement of urine. It is intended to be used as a urological catheter inserted through the urethra for the purpose of draining urine and other fluids from the urinary tract. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as the nephrostomy tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090262 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090262: Percucath Urinary Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090262
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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