510(k) · Cleared
Recalled · Class II · 2024Ureteral Dilators and Percutaneous Nephrostomy Dilators
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 Aug 17, 2017 as substantially equivalent to K961904 (Cook Urological, Inc., 1996) after a 176-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 17, 2017
- Review
- 176 days
- Class
- Class II
- Product code
- EZN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961904 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK961904 AQ Hydrophilic DilatorsCook Urological, Inc. · 1996
- This deviceK170531 Ureteral Dilators and Percutaneous Nephrostomy DilatorsColoplast Corp. · 2017
- Descendant · cites it directly · 0 of its ownK250448 Disposable Percutaneous Nephrostomy Dilatation KitShenzhen Trious Medical Technology Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K250448Disposable Percutaneous Nephrostomy Dilatation KitShenzhen Trious Medical Technology Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961904 | AQ Hydrophilic Dilators | Cook Urological, Inc. | 1996 | — |
| 0 (this device) | K170531 | Ureteral Dilators and Percutaneous Nephrostomy Dilators | Coloplast Corp. | 2017 | — |
| +1 | K250448 | Disposable Percutaneous Nephrostomy Dilatation Kit | Shenzhen Trious Medical Technology Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K961904 | AQ Hydrophilic DilatorsSummary page 4…lators are substantially equivalent in performance, indication, design and materials to Cook Medical AQ® Hydrophilic Dilator, cleared under premarket notification number K961904. Device Description: Ureteral dilators: The Ureteral Dilators are hollow rigid tubes made of Polyether Block Amide (PEBA)… | 1996 |
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 |
|---|---|---|---|
| K250448 | Disposable Percutaneous Nephrostomy Dilatation Kit | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 11, 2024 | Class II | Z-1463-2024 | Under Investigation by firm | A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facility on some ureteral dilator products. This issue on the ureteral dilator packaging has been identified during testing in our facility. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All EZN devicesEZN Dilator, Catheter, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Ureteral Dilators:
Intended to be used for dilatation of the ureter during ureteroscopic procedures.
Percutaneous Nephrostomy Dilators:
Dilator for tract preparation or splittable working sheath to protect the parenchyma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170531 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170531: Ureteral Dilators and Percutaneous Nephrostomy Dilators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170531
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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