510(k) · Cleared
ClearedConvertX Biliary Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brightwater Medical · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Mar 14, 2019 as substantially equivalent to K101786 (Boston Scientific Corp, 2010) and 1 other predicate after a 262-day review. Its family tree reaches back 3 generations to 1984.
- Decided
- Mar 14, 2019
- Review
- 262 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K834468 (1984). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK834468 Drainage StentMicrovasive · 1984 · Recalled
- 2 generations backK965147 Biliary Stent, Biliary Stent System, Biliary EndoprosthesisBoston Scientific Corp · 1997 · Recalled
- 1 generation backK101786 Advanix Double Pigtail Biliary StentBoston Scientific Corp · 2010
- This deviceK181669 ConvertX Biliary Stent SystemBrightwater Medical · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K834468 | Drainage Stent | Microvasive | 1984 | 2 |
| −2 | K965147 | Biliary Stent, Biliary Stent System, Biliary Endoprosthesis | Boston Scientific Corp | 1997 | 23 |
| −1 | K101786 | Advanix Double Pigtail Biliary Stent | Boston Scientific Corp | 2010 | — |
| 0 (this device) | K181669 | ConvertX Biliary Stent System | Brightwater Medical | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2002 | 1 | 0 |
| 2014 | 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 FGE? 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 FGE device
- #1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 13 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 |
|---|---|---|---|
| * | K101786 | Advanix Double Pigtail Biliary StentSummary page 4…sories Classification Panel Gastroenterology/Urology Product Code FGE Predicate Devices Boston Scientific AdvanixTM Double Pigtail (K101786), Boston Scientific ExpelTM Drainage Catheter (K141335) Reference Device BrightWater Me… | 2010 |
| * | K141335 | Expel Apd Drainage Catheter SystemSummary page 4…FGE Predicate Devices Boston Scientific AdvanixTM Double Pigtail (K101786), Boston Scientific ExpelTM Drainage Catheter (K141335) Reference Device BrightWater Medical ConvertX Nephroureteral Stent System (K161277)… | 2014 |
| † | K161277 | ConvertX Nephroureteral Stent System | 2016 |
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 35 years and passes through 3 companies; a new generation was cleared every 13.1 years on median.
- 5 of the 6 ancestors have a recall of any class.
How does its category compare?
All FGE devicesFGE Stents, Drains And Dilators For The Biliary Ducts: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · FGE
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGE
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGE
1,923in 2025
MAUDE reports naming product code FGE, 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 | 4 | 316 | 54 | 1,006 |
| 2008 | 11 | 214 | 93 | 1,465 |
| 2009 | 7 | 160 | 18 | 1,655 |
| 2010 | 9 | 81 | 32 | 1,434 |
| 2011 | 9 | 114 | 2 | 1,321 |
| 2012 | 8 | 96 | 4 | 1,183 |
| 2013 | 5 | 161 | 3 | 1,060 |
| 2014 | 8 | 156 | 0 | 1,270 |
| 2015 | 8 | 79 | 0 | 1,543 |
| 2016 | 4 | 49 | 0 | 1,453 |
| 2017 | 9 | 59 | 1 | 1,515 |
| 2018 | 7 | 215 | 43 | 1,681 |
| 2019 | 2 | — | 13 | 1,896 |
| 2020 | 4 | 121 | 1 | 2,182 |
| 2021 | 1 | — | 27 | 2,297 |
| 2022 | 6 | 101 | 21 | 1,749 |
| 2023 | 6 | 199 | 19 | 1,615 |
| 2024 | 6 | 188 | 1 | 1,948 |
| 2025 | 7 | 257 | 0 | 1,923 |
| 2026 | 8 | 153 | 11 | — |
What is it indicated for?
The ConvertX Biliary Stent System with releasable drainage catheter is delivered percutaneously and is intended for internal drainage of the bile ducts, for splinting of the bile ducts during healing, or for providing bile duct patency in a stricture or past a stone 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 bile duct to the duodenum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181669 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181669: ConvertX Biliary Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181669
Report an extraction error
Are you the manufacturer?
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