510(k) · Cleared
ClearedOptilume® High Pressure Urological Balloon Dilation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Urotronic, Inc. · EZN Dilator, Catheter, Ureteral
Cleared on May 22, 2025 as substantially equivalent to K130804 (Boston Scientific Corporation, 2013) after a 57-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- May 22, 2025
- Review
- 57 days
- Class
- Class II
- Product code
- EZN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K952968 (1995). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK952968 Dilatation Catheter, BalloonBoston Scientific Corp · 1995
- 2 generations backK121614 Nephromax High Pressure Nephrostomy Baloon Dilatation CatheterBoston Scientific Corp · 2012 · Recalled
- 1 generation backK130804 Uromax Ultra Balloon Dilatation CatheterBoston Scientific Corporation · 2013 · Recalled
- This deviceK250910 Optilume® High Pressure Urological Balloon Dilation CatheterUrotronic, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K952968 | Dilatation Catheter, Balloon | Boston Scientific Corp | 1995 | — |
| −2 | K121614 | Nephromax High Pressure Nephrostomy Baloon Dilatation Catheter | Boston Scientific Corp | 2012 | 3 |
| −1 | K130804 | Uromax Ultra Balloon Dilatation Catheter | Boston Scientific Corporation | 2013 | 1 |
| 0 (this device) | K250910 | Optilume® High Pressure Urological Balloon Dilation Catheter | Urotronic, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 EZN? 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 EZN device
- #1 K201007 In-Ka Ureteral Balloon Dilatation Catheterscore -0.5 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K130804 | Uromax Ultra Balloon Dilatation CatheterSummary page 5…ially equivalent in performance, indication, design and materials to Uromax Ultra™ High Pressure Balloon Dilatation Catheter, cleared under premarket notification number K130804. K250910… | 2013 |
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 30 years and passes through 3 companies; a new generation was cleared every 12.0 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 3 other devices also cite its predicate K130804.
How does its category compare?
All EZN devicesEZN Dilator, Catheter, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · EZN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EZN
175in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EZN
9in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EZN
79in 2025
MAUDE reports naming product code EZN, 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 | 0 | — | 9 | 23 |
| 2008 | 0 | — | 0 | 53 |
| 2009 | 0 | — | 0 | 124 |
| 2010 | 0 | — | 0 | 52 |
| 2011 | 0 | — | 0 | 54 |
| 2012 | 0 | — | 0 | 38 |
| 2013 | 2 | — | 0 | 27 |
| 2014 | 0 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 30 |
| 2016 | 0 | — | 0 | 19 |
| 2017 | 1 | — | 0 | 65 |
| 2018 | 4 | 175 | 0 | 58 |
| 2019 | 1 | — | 0 | 56 |
| 2020 | 1 | — | 0 | 40 |
| 2021 | 0 | — | 0 | 41 |
| 2022 | 0 | — | 0 | 51 |
| 2023 | 1 | — | 0 | 83 |
| 2024 | 0 | — | 0 | 49 |
| 2025 | 1 | — | 0 | 79 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Optilume® High Pressure Urological Balloon Dilation Catheter is indicated for dilation of the urinary tract.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250910 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250910: Optilume® High Pressure Urological Balloon Dilation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250910
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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