510(k) · Cleared
Recalled · Class II · 2025Uromax Ultra Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · EZN Dilator, Catheter, Ureteral
Cleared on May 22, 2013 as substantially equivalent to K980795 (Boston Scientific Corp, 1998) and 1 other predicate after a 58-day review. Its family tree reaches back 2 generations to 1995. 4 later devices descend from it. It has been recalled once.
- Decided
- May 22, 2013
- Review
- 58 days
- Class
- Class II
- Product code
- EZN
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K952968 (1995). 3 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK952968 Dilatation Catheter, BalloonBoston Scientific Corp · 1995
- 1 generation backK121614 Nephromax High Pressure Nephrostomy Baloon Dilatation CatheterBoston Scientific Corp · 2012 · Recalled
- This deviceK130804 Uromax Ultra Balloon Dilatation CatheterBoston Scientific Corporation · 2013
- Descendant · cites it directly · 0 of its ownK250910 Optilume® High Pressure Urological Balloon Dilation CatheterUrotronic, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK191061 Optilume Basic Urological Balloon Dilation CatheterUrotronic, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK190612 EQUINOX Balloon Dilatation CatheterDornier Medtech America, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK132181 Gyrus Acmi Uro-Ezdilate Ureteral Balloon Dilation CatheterOlympus Surgical Technologies America · 2013
Most influential descendants
Showing 4 of 4 · See all- K250910Optilume® High Pressure Urological Balloon Dilation CatheterUrotronic, Inc. · 2025 · cites it directly0descendants
- K191061Optilume Basic Urological Balloon Dilation CatheterUrotronic, Inc. · 2020 · cites it directly0descendants
- K190612EQUINOX Balloon Dilatation CatheterDornier Medtech America, Inc. · 2019 · cites it directly0descendants
- K132181Gyrus Acmi Uro-Ezdilate Ureteral Balloon Dilation CatheterOlympus Surgical Technologies America · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952968 | Dilatation Catheter, Balloon | Boston Scientific Corp | 1995 | — |
| −1 | K121614 | Nephromax High Pressure Nephrostomy Baloon Dilatation Catheter | Boston Scientific Corp | 2012 | 3 |
| 0 (this device) | K130804 | Uromax Ultra Balloon Dilatation Catheter | Boston Scientific Corporation | 2013 | — |
| +1 | K250910 | Optilume® High Pressure Urological Balloon Dilation Catheter | Urotronic, Inc. | 2025 | — |
| +1 | K191061 | Optilume Basic Urological Balloon Dilation Catheter | Urotronic, Inc. | 2020 | — |
| +1 | K190612 | EQUINOX Balloon Dilatation Catheter | Dornier Medtech America, Inc. | 2019 | — |
| +1 | K132181 | Gyrus Acmi Uro-Ezdilate Ureteral Balloon Dilation Catheter | Olympus Surgical Technologies America | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 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 K250910 Optilume® High Pressure Urological Balloon…score 10.0 · 3 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K980795 | Urological Balloon Dilatation CatheterSummary page 1…lator, Catheter, Ureteral Classification: 21 CFR 876.5470, 2 1CFR 876.5520 Product Code: EZN, KOF Prernarket Notification: Boston Scientific, K980795 Trade name: Neplirornax TMHigh Pressure Balloon Dilatation Catheter Common usual/name: Catheter, Nephro… | 1998 |
| * | K121614 | Nephromax High Pressure Nephrostomy Baloon Dilatation CatheterSummary page 1…theter, Nephrostomy Classification: LJE- Catheter, Nephrostomy Pre-Amendment Premarket Notification: Boston Scientific, K 121614 Page 25 of 219… | 2012 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 5, 2025 | Class II | Z-2536-2025 | Under Investigation by firm | The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 17.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K250910 (Urotronic, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EZN devicesEZN Dilator, Catheter, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Uromax Ultra TM Balloon Dilatation Catheters are recommended for
dilatation of the urinary tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130804 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130804: Uromax Ultra Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130804
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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