510(k) · Cleared
ClearedUreteral Dilator Sets, Ureteral Dilators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · EZN Dilator, Catheter, Ureteral
Cleared on Jul 17, 2018 as substantially equivalent to K961904 (Cook Urological, Inc., 1996) after a 231-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Jul 17, 2018
- Review
- 231 days
- Class
- Class II
- Product code
- EZN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961904 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK961904 AQ Hydrophilic DilatorsCook Urological, Inc. · 1996
- This deviceK173654 Ureteral Dilator Sets, Ureteral DilatorsCook Incorporated · 2018
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) | K173654 | Ureteral Dilator Sets, Ureteral Dilators | Cook Incorporated | 2018 | — |
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…logy Predicate Device: The Ureteral Dilator Sets, and each individual Ureteral Dilator, is substantially equivalent to the following device: the AQ Hydrophilic Dilator (K961904, Cook Urological Inc.) cleared on October 18, 1996. Device Description: The Ureteral Dilator Sets, and each individual Ureteral… | 1996 |
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 no recall.
- 4 other devices also cite its predicate K961904.
How does its category compare?
All EZN devicesEZN Dilator, Catheter, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Ureteral Dilator Sets are intended for the dilation of the ureter prior to ureteroscopy or stone manipulation.
The Ureteral Dilators are intended for the dilation of the ureter prior to ureteroscopy or stone manipulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173654: Ureteral Dilator Sets, Ureteral Dilators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173654
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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