510(k) · Decided
DecidedBoston Scientific Express Biliary LD Unmounted Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Mar 25, 2003 as substantially equivalent to K021630 (Boston Scientific Corp, 2002) and 1 other predicate after a 25-day review. Its family tree reaches back 6 generations to 1991. 2 later devices descend from it.
- Decided
- Mar 25, 2003
- Review
- 25 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K905720 (1991). 14 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK905720 Palmaz Biliary StentJohnson & Johnson Interventional Systems · 1991
- 5 generations backK990631 Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis Corp. · 1999
- 4 generations backK991028 Cordis Palmaz Corinthian Transhepatic Biliary Stent and AccessoriesCordis Corp. · 1999
- 3 generations backK992755 Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis, A Johnson & Johnson Co. · 1999
- 2 generations backK021630 Boston Scientific Express Biliary LD Premounted Stent SystemBoston Scientific Corp · 2002
- 1 generation backK024048 Modification to Boston Scientific Express Biliary LD Premounted…Boston Scientific Scimed, Inc. · 2003
- This deviceK030645 Boston Scientific Express Biliary LD Unmounted StentBoston Scientific Corp · 2003
- Descendant · cites it directly · 1 of its ownK032360 Modification to Boston Scientific Express Biliary LD Premounted…Boston Scientific Corp · 2003
- Descendant · 2 generations on · 0 of its ownK133110 Express LD Biliary Premounted Stent SystemBoston Scientific Corporation · 2014
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 |
|---|---|---|---|---|---|
| −6 | K905720 | Palmaz Biliary Stent | Johnson & Johnson Interventional Systems | 1991 | — |
| −5 | K990631 | Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model… | Cordis Corp. | 1999 | — |
| −4 | K991028 | Cordis Palmaz Corinthian Transhepatic Biliary Stent and Accessories | Cordis Corp. | 1999 | — |
| −3 | K992755 | Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System… | Cordis, A Johnson & Johnson Co. | 1999 | — |
| −2 | K021630 | Boston Scientific Express Biliary LD Premounted Stent System | Boston Scientific Corp | 2002 | — |
| −1 | K024048 | Modification to Boston Scientific Express Biliary LD Premounted Stent System | Boston Scientific Scimed, Inc. | 2003 | — |
| 0 (this device) | K030645 | Boston Scientific Express Biliary LD Unmounted Stent | Boston Scientific Corp | 2003 | — |
| +1 | K032360 | Modification to Boston Scientific Express Biliary LD Premounted Stent System… | Boston Scientific Corp | 2003 | — |
| +2 | K133110 | Express LD Biliary Premounted Stent System | Boston Scientific Corporation | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 |
|---|---|---|---|
| * | K021630 | Boston Scientific Express Biliary LD Premounted Stent System | 2002 |
| * | K024048 | Modification to Boston Scientific Express Biliary LD Premounted Stent SystemSummary page 1…Description The Express Biliary LD Unmounted Stent will be the identical stent that is currently marketed as the Express Biliary LD Premounted Stent System (KO21630 and K024048). The stent will be hand mounted by the user upon its recommended balloon delivery catheter. The Express Biliary LD Stent is a b… | 2003 |
| † | K011889 | Ultra -Thin SDS Balloon Dilatation Catheter | 2001 |
| † | K011909 | Ultra-Thin SDS Balloon Dilatation Catheter | 2001 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032360 | Modification to Boston Scientific Express Biliary LD Premounted Stent System and Express… | 2003 | 1 |
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 12 years and passes through 5 companies; a new generation was cleared every 3 months on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K032360 (Boston Scientific Corp, 2003) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K021630.
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.
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 Boston Scientific Express™ Biliary LD Unmounted Stent is indicated for use in the palliation of malignant neoplasms in the biliary tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030645 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030645: Boston Scientific Express Biliary LD Unmounted Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030645
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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