510(k) · Cleared
ClearedTria Firm Ureteral Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · FAD Stent, Ureteral
Cleared on May 24, 2019 as substantially equivalent to K163399 (Boston Scientific Corporation, 2017) after a 77-day review. Its family tree reaches back 2 generations to 1998. 2 later devices descend from it.
- Decided
- May 24, 2019
- Review
- 77 days
- Class
- Class II
- Product code
- FAD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K974541 (1998). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK974541 Modified Ureteral Indwelling Catheter/StentBoston Scientific Corp · 1998 · Recalled
- 1 generation backK163399 Tria Firm Ureteral StentBoston Scientific Corporation · 2017
- This deviceK190603 Tria Firm Ureteral StentBoston Scientific Corporation · 2019
- Descendant · cites it directly · 0 of its ownK250824 Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex…Boston Scientific Corporation · 2025
- Descendant · cites it directly · 0 of its ownK191609 Tria Soft Ureteral StentBoston Scientific Corporation · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974541 | Modified Ureteral Indwelling Catheter/Stent | Boston Scientific Corp | 1998 | 2 |
| −1 | K163399 | Tria Firm Ureteral Stent | Boston Scientific Corporation | 2017 | — |
| 0 (this device) | K190603 | Tria Firm Ureteral Stent | Boston Scientific Corporation | 2019 | — |
| +1 | K250824 | Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus… | Boston Scientific Corporation | 2025 | — |
| +1 | K191609 | Tria Soft Ureteral Stent | Boston Scientific Corporation | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K163399 | Tria Firm Ureteral StentSummary page 4…s II Product Code: FAD Product Code Name: Stent, Ureteral Identification of Predicate Device: Tria Firm Ureteral Stent, K163399 Proprietary and Confidential Information of Boston Scientific Corporation… | 2017 |
What descends from it? (2)
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)
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 21 years and passes through 2 companies; a new generation was cleared every 19.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K250824 (Boston Scientific Corporation, 2025) has gone furthest, with 0 descendants 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. 2019, 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 Ureteral Stent is intended to facilitate drainage from the kidney to the bladder via placement endoscopically,
fluoroscopically or during an open surgical procedure by a trained physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190603 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190603: Tria Firm Ureteral Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190603
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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