510(k) · Decided
DecidedIn-Ka Ureteral Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast Corp. · EZN Dilator, Catheter, Ureteral
Cleared on Jun 11, 2020 as substantially equivalent to K993840 (C.R. Bard, Inc., 2000) after a 55-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Jun 11, 2020
- Review
- 55 days
- Class
- Class II
- Product code
- EZN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993840 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK993840 Bard Uroforce Balloon Dilation CatheterC.R. Bard, Inc. · 2000 · Recalled
- This deviceK201007 In-Ka Ureteral Balloon Dilatation CatheterColoplast Corp. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993840 | Bard Uroforce Balloon Dilation Catheter | C.R. Bard, Inc. | 2000 | 1 |
| 0 (this device) | K201007 | In-Ka Ureteral Balloon Dilatation Catheter | Coloplast Corp. | 2020 | — |
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
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 |
|---|---|---|---|
| * | K993840 | Bard Uroforce Balloon Dilation CatheterSummary page 4…are substantially equivalent in performance, indication, design and materials to Bard® Uroforce™ Balloon Dilation Catheters, cleared under premarket notification number K993840. This predicate has not been subject to a design-related recall. No reference devices were used in this submission. IV. DEV… | 2000 |
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?
- Its one ancestor has a recall.
How does its category compare?
All EZN devicesEZN Dilator, Catheter, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
In-Ka ureteral balloon dilatation catheters are intended for:
• Dilation of ureteral meatus and/or ureteral canal during endoscopic procedures
• Treatment of ureteral stenosis
Target population
Patients requiring endourologic procedures and/or presenting with ureteral stenosis.
Duration of Use
In-Ka ureteral balloon dilatation catheters are intended for transient use (less than 1 hour).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201007 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201007: In-Ka Ureteral 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/K201007
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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