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 Jun 22, 2017 as substantially equivalent to K974541 (Boston Scientific Corp, 1998) after a 199-day review. Its family tree reaches back 1 generation to 1998. 3 later devices descend from it.
- Decided
- Jun 22, 2017
- Review
- 199 days
- Class
- Class II
- Product code
- FAD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974541 (1998). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK974541 Modified Ureteral Indwelling Catheter/StentBoston Scientific Corp · 1998 · Recalled
- This deviceK163399 Tria Firm Ureteral StentBoston Scientific Corporation · 2017
- Descendant · cites it directly · 2 of its ownK190603 Tria Firm Ureteral StentBoston Scientific Corporation · 2019
- Descendant · 2 generations on · 0 of its ownK250824 Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex…Boston Scientific Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK191609 Tria Soft Ureteral StentBoston Scientific Corporation · 2019
Most influential descendants
Showing 3 of 3 · See all- K190603Tria Firm Ureteral StentBoston Scientific Corporation · 2019 · cites it directly2descendants
- K250824Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive…Boston Scientific Corporation · 2025 · 2 generations on0descendants
- K191609Tria Soft Ureteral StentBoston Scientific Corporation · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974541 | Modified Ureteral Indwelling Catheter/Stent | Boston Scientific Corp | 1998 | 2 |
| 0 (this device) | K163399 | Tria Firm Ureteral Stent | Boston Scientific Corporation | 2017 | — |
| +1 | K190603 | Tria Firm Ureteral Stent | Boston Scientific Corporation | 2019 | — |
| +2 | K250824 | Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus… | Boston Scientific Corporation | 2025 | — |
| +2 | K191609 | Tria Soft Ureteral Stent | Boston Scientific Corporation | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 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 |
|---|---|---|---|
| * | K974541 | Modified Ureteral Indwelling Catheter/StentSummary page 4…ent, ureteral Classification Name: FAD – Stent, Ureteral Premarket Notification: Contour™ (Modified Ureteral Indwelling Catheter/Stent) Ureteral Stent, K974541, Sep 02, 1998. The Contour Ureteral Stent has not been the subject of a design-related recall. Reference 1 Trade na… | 1998 |
| † | K834468 | Drainage Stent | 1984 |
| † | K133700 | Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic Delivery System and… | 2014 |
| † | K022447 | Bard ER Ureteral Stent with Suture | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190603 | Tria Firm Ureteral Stent | 2019 | 2 |
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 a recall.
- Of its descendants, K190603 (Boston Scientific Corporation, 2019) has gone furthest, with 2 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. 2017, 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/K163399 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163399: Tria Firm Ureteral Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163399
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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