510(k) · Decided
DecidedEndura™ Ureteral Stent and Stent Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cathegenix (Xiamen) Co., Ltd. · FAD Stent, Ureteral
Cleared on Dec 19, 2025 as substantially equivalent to K022447 (C.R. Bard, Inc., 2003) after a 220-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Dec 19, 2025
- Review
- 220 days
- Class
- Class II
- Product code
- FAD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K903345 (1991). No later device cites it as a predicate yet.
- Root · 3 generations backK903345 Bard (R) Lubricious - Coated Ureteral Stent SutureC.R. Bard, Inc. · 1991
- 2 generations backK983498 Bard Inlay Lubricious Double Pigtail Ureteral Stent with Suture…C.R. Bard, Inc. · 1998 · Recalled
- 1 generation backK022447 Bard ER Ureteral Stent with SutureC.R. Bard, Inc. · 2003
- This deviceK251469 Endura™ Ureteral Stent and Stent SetCathegenix (Xiamen) Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K903345 | Bard (R) Lubricious - Coated Ureteral Stent Suture | C.R. Bard, Inc. | 1991 | — |
| −2 | K983498 | Bard Inlay Lubricious Double Pigtail Ureteral Stent with Suture (Hereinafter… | C.R. Bard, Inc. | 1998 | 2 |
| −1 | K022447 | Bard ER Ureteral Stent with Suture | C.R. Bard, Inc. | 2003 | — |
| 0 (this device) | K251469 | Endura™ Ureteral Stent and Stent Set | Cathegenix (Xiamen) Co., Ltd. | 2025 | — |
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 FAD? 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 FAD device
- #1 K251890 Disposable Ureteral Stentsscore 12.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K022447 | Bard ER Ureteral Stent with SutureSummary page 5…on: 21 CFR 876.4620 Product Code: FAD Device Class: 2 3. Identification of Predicate Devices Bard® InLay Optima™ Ureteral Stent cleared under K022447. 4. Intended Use/Indications for Use The device is indicated to relieve obstruction in a variety of benign, malignant, and post… | 2003 |
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?
- The line of descent spans 34 years and passes through 2 companies; a new generation was cleared every 7.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K022447.
How does its category compare?
All FAD devicesFAD Stent, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · FAD
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FAD
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FAD
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAD
634in 2025
MAUDE reports naming product code FAD, 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 | 1 | — | 1 | 43 |
| 2008 | 1 | — | 22 | 76 |
| 2009 | 0 | — | 2 | 123 |
| 2010 | 1 | — | 1 | 78 |
| 2011 | 0 | — | 0 | 95 |
| 2012 | 0 | — | 0 | 131 |
| 2013 | 0 | — | 0 | 82 |
| 2014 | 1 | — | 0 | 78 |
| 2015 | 0 | — | 0 | 130 |
| 2016 | 4 | 143 | 4 | 182 |
| 2017 | 8 | 266 | 0 | 265 |
| 2018 | 9 | 258 | 0 | 277 |
| 2019 | 5 | 263 | 6 | 261 |
| 2020 | 1 | — | 2 | 352 |
| 2021 | 2 | — | 1 | 531 |
| 2022 | 5 | 143 | 9 | 559 |
| 2023 | 0 | — | 0 | 691 |
| 2024 | 1 | — | 0 | 603 |
| 2025 | 4 | 186 | 4 | 634 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The device is indicated to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions in the ureter. The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic techniques. It is recommended that the indwelling time not exceed 365 days. The stent is not intended as a permanent indwelling device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251469 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251469: Endura™ Ureteral Stent and Stent Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251469
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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