510(k) · Decided
DecidedUreteral Stent Systems, Biliary Drainage Catheters
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 Jan 2, 2020 as substantially equivalent to K023870 (Boston Scientific/Medi-Tech, 2002) and 1 other predicate after a 216-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Jan 2, 2020
- Review
- 216 days
- Class
- Class II
- Product code
- FAD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K944290 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK944290 Catheters, Biliary Catheters, UrologicalBoston Scientific Corp · 1994 · Recalled
- This deviceK191446 Ureteral Stent Systems, Biliary Drainage CathetersBoston Scientific Corporation · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944290 | Catheters, Biliary Catheters, Urological | Boston Scientific Corp | 1994 | 5 |
| 0 (this device) | K191446 | Ureteral Stent Systems, Biliary Drainage Catheters | Boston Scientific Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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? (2)
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 |
|---|---|---|---|
| * | K023870 | Flexima Biliary CatheterSummary page 7…FAD stent, ureteral II Systems 876.4620 III. PREDICATE DEVICE IDENTIFICATION Name of Predicate Device Flexima Biliary Catheter K023870 (Predicate for Flexima Biliary Catheters) Flexima Drainage Catheters and Stents K944290 (Predicate for Flexima Ureteral Stents)… | 2002 |
| * | K944290 | Catheters, Biliary Catheters, UrologicalSummary page 7…DICATE DEVICE IDENTIFICATION Name of Predicate Device Flexima Biliary Catheter K023870 (Predicate for Flexima Biliary Catheters) Flexima Drainage Catheters and Stents K944290 (Predicate for Flexima Ureteral Stents) Predicate devices referenced above have not been subject to a design-related recall. IV… | 1994 |
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?
- 2 of the 2 ancestors have a recall of any class.
- 3 other devices also cite its predicate K023870.
How does its category compare?
All FAD devicesFAD Stent, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Flexima™ Ureteral Stent System and Flexima™ Ureteral Stent System Kit is intended to provide drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not extend externally.
The Flexima™ Biliary Catheter System / Flexima™ Biliary Catheter System Kit / Flexima™ Biliary Catheter System with Radiopaque Marker / Flexima™ Biliary Catheter System with Hydrophilic Dissolving Tip / Flexima™ Biliary Catheter System with Hydrophilic Dissolving Tip and Radiopaque Marker are intended to provide external and internal percutaneous drainage of the biliary system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191446 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191446: Ureteral Stent Systems, Biliary Drainage Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191446
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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