510(k) · Cleared
ClearedUrological Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · EZN Dilator, Catheter, Ureteral
Cleared on Apr 22, 1998 after a 51-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- Apr 22, 1998
- Review
- 51 days
- Class
- Class II
- Product code
- EZN
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK980795 Urological Balloon Dilatation CatheterBoston Scientific Corp · 1998
- Descendant · cites it directly · 4 of its ownK130804 Uromax Ultra Balloon Dilatation CatheterBoston Scientific Corporation · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK250910 Optilume® High Pressure Urological Balloon Dilation CatheterUrotronic, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK191061 Optilume Basic Urological Balloon Dilation CatheterUrotronic, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK190612 EQUINOX Balloon Dilatation CatheterDornier Medtech America, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK132181 Gyrus Acmi Uro-Ezdilate Ureteral Balloon Dilation CatheterOlympus Surgical Technologies America · 2013
Most influential descendants
Showing 5 of 5 · See all- K130804Uromax Ultra Balloon Dilatation CatheterBoston Scientific Corporation · 2013 · cites it directly4descendants
- K250910Optilume® High Pressure Urological Balloon Dilation CatheterUrotronic, Inc. · 2025 · 2 generations on0descendants
- K191061Optilume Basic Urological Balloon Dilation CatheterUrotronic, Inc. · 2020 · 2 generations on0descendants
- K190612EQUINOX Balloon Dilatation CatheterDornier Medtech America, Inc. · 2019 · 2 generations on0descendants
- K132181Gyrus Acmi Uro-Ezdilate Ureteral Balloon Dilation CatheterOlympus Surgical Technologies America · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980795 | Urological Balloon Dilatation Catheter | Boston Scientific Corp | 1998 | — |
| +1 | K130804 | Uromax Ultra Balloon Dilatation Catheter | Boston Scientific Corporation | 2013 | 1 |
| +2 | K250910 | Optilume® High Pressure Urological Balloon Dilation Catheter | Urotronic, Inc. | 2025 | — |
| +2 | K191061 | Optilume Basic Urological Balloon Dilation Catheter | Urotronic, Inc. | 2020 | — |
| +2 | K190612 | EQUINOX Balloon Dilatation Catheter | Dornier Medtech America, Inc. | 2019 | — |
| +2 | K132181 | Gyrus Acmi Uro-Ezdilate Ureteral Balloon Dilation Catheter | Olympus Surgical Technologies America | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 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?
The FDA summary names no predicate by number.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130804 | Uromax Ultra Balloon Dilatation Catheter | 2013 | 4 |
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?
- Of its descendants, K130804 (Boston Scientific Corporation, 2013) has gone furthest, with 4 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.
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?
BD-3 Catheters are intended for urological dilatation; ureteral and urethral.
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/K980795 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980795: Urological 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/K980795
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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