510(k) · Cleared
ClearedConvertX Nephroureteral Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brightwater Medical · FAD Stent, Ureteral
Cleared on Nov 22, 2016 as substantially equivalent to K141344 (Boston Scientific Corp, 2014) after a 200-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Nov 22, 2016
- Review
- 200 days
- Class
- Class II
- Product code
- FAD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K924608 (1994). No later device cites it as a predicate yet.
- Root · 2 generations backK924608 Hydrogel Coated Percuflex (R) Drainage CathetersBoston Scientific Corp · 1994
- 1 generation backK141344 Expel Nephroureteral Drainage Stent with Twist-Loc Hub System, Expel…Boston Scientific Corp · 2014
- This deviceK161277 ConvertX Nephroureteral Stent SystemBrightwater Medical · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K924608 | Hydrogel Coated Percuflex (R) Drainage Catheters | Boston Scientific Corp | 1994 | — |
| −1 | K141344 | Expel Nephroureteral Drainage Stent with Twist-Loc Hub System, Expel Ureteral… | Boston Scientific Corp | 2014 | — |
| 0 (this device) | K161277 | ConvertX Nephroureteral Stent System | Brightwater Medical | 2016 | — |
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 |
|---|---|---|---|
| * | K141344 | Expel Nephroureteral Drainage Stent with Twist-Loc Hub System, Expel Ureteral Drainage…Summary page 4…Class II Regulation Number 21 CFR 876.4620 Classification Panel Gastroenterology/Urology Product Code FAD Predicate Device K141344, Expel Nephroureteral Stent System with Twist-Loc Hub and Expel Ureteral Stent System Intended Use… | 2014 |
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 22 years and passes through 2 companies; a new generation was cleared every 20.7 years on median.
- None of the 2 ancestors has a recall.
- 5 other devices also cite its predicate K141344.
How does its category compare?
All FAD devicesFAD Stent, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 ConvertX Nephroureteral Stent System with releasable drainage catheter is delivered percutaneously and is intended to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent, as well as providing external drainage.
For patients for whom external drainage is not, or no longer desirable, the releasable drainage catheter may be removed, leaving the stent to provide internal drainage from the ureteropelvic junction to the bladder.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161277 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161277: ConvertX Nephroureteral Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161277
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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