510(k) · Cleared
Recalled · 2006Contour Polaris Ureteral Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · FAD Stent, Ureteral
Cleared on Jan 22, 2001 after a 20-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled once.
- Decided
- Jan 22, 2001
- Review
- 20 days
- Class
- Class II
- Product code
- FAD
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK010002 Contour Polaris Ureteral StentBoston Scientific Corp · 2001
- Descendant · cites it directly · 1 of its ownK030503 Modification to Contour Polaris Ureteral StentBoston Scientific Corp · 2003
- Descendant · 2 generations on · 0 of its ownK212868 JFil Ureteral Stents, JFil Ureteral Stents ECO KITRocamed Sam · 2022
- Descendant · cites it directly · 0 of its ownK162109 Kwart Retro-Inject Ureteral StentCook Incorporated · 2017 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K030503Modification to Contour Polaris Ureteral StentBoston Scientific Corp · 2003 · cites it directly1descendant
- K212868JFil Ureteral Stents, JFil Ureteral Stents ECO KITRocamed Sam · 2022 · 2 generations on0descendants
- K162109Kwart Retro-Inject Ureteral StentCook Incorporated · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010002 | Contour Polaris Ureteral Stent | Boston Scientific Corp | 2001 | — |
| +1 | K030503 | Modification to Contour Polaris Ureteral Stent | Boston Scientific Corp | 2003 | — |
| +2 | K212868 | JFil Ureteral Stents, JFil Ureteral Stents ECO KIT | Rocamed Sam | 2022 | — |
| +1 | K162109 | Kwart Retro-Inject Ureteral Stent | Cook Incorporated | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 10, 2006 | Not classified | Z-1238-06 | Other | Instructions on how to inject are not included in the package. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K030503 (Boston Scientific Corp, 2003) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FAD devicesFAD Stent, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K010002 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010002: Contour Polaris Ureteral Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010002
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026