510(k) · Decided
DecidedExpress LD Biliary Premounted Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Jul 2, 2014 as substantially equivalent to K021630 (Boston Scientific Corp, 2002) and 2 other predicates after a 275-day review. Its family tree reaches back 8 generations to 1991.
- Decided
- Jul 2, 2014
- Review
- 275 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K905720 (1991). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK905720 Palmaz Biliary StentJohnson & Johnson Interventional Systems · 1991
- 7 generations backK990631 Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis Corp. · 1999
- 6 generations backK991028 Cordis Palmaz Corinthian Transhepatic Biliary Stent and AccessoriesCordis Corp. · 1999
- 5 generations backK992755 Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis, A Johnson & Johnson Co. · 1999
- 4 generations backK021630 Boston Scientific Express Biliary LD Premounted Stent SystemBoston Scientific Corp · 2002
- 3 generations backK024048 Modification to Boston Scientific Express Biliary LD Premounted…Boston Scientific Scimed, Inc. · 2003
- 2 generations backK030645 Boston Scientific Express Biliary LD Unmounted StentBoston Scientific Corp · 2003
- 1 generation backK032360 Modification to Boston Scientific Express Biliary LD Premounted…Boston Scientific Corp · 2003
- This deviceK133110 Express LD Biliary Premounted Stent SystemBoston Scientific Corporation · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K905720 | Palmaz Biliary Stent | Johnson & Johnson Interventional Systems | 1991 | — |
| −7 | K990631 | Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model… | Cordis Corp. | 1999 | — |
| −6 | K991028 | Cordis Palmaz Corinthian Transhepatic Biliary Stent and Accessories | Cordis Corp. | 1999 | — |
| −5 | K992755 | Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System… | Cordis, A Johnson & Johnson Co. | 1999 | — |
| −4 | K021630 | Boston Scientific Express Biliary LD Premounted Stent System | Boston Scientific Corp | 2002 | — |
| −3 | K024048 | Modification to Boston Scientific Express Biliary LD Premounted Stent System | Boston Scientific Scimed, Inc. | 2003 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
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? (3)
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 SystemSummary page 1…ry Premounted Stent System is substantially equivalent to the predicate Express LID Biliary Premounted Stent System which was cleared by FDA under premarket notification K021630 (October 25, 2Q02). The proposed Express LD Biliary Premounted Stent System has the same intended use and device performance as t… | 2002 |
| * | K024048 | Modification to Boston Scientific Express Biliary LD Premounted Stent SystemSummary page 1…posed Express LD Biliary Premounted Stent System has the same intended use and device performance as the predicates Express LID Biliary Premounted Stent System (K021630, K024048, and K032360). Boston Scientific Corporation Confidential Attachment 5 - Page 1of 3 === Page 2… | 2003 |
| * | K032360 | Modification to Boston Scientific Express Biliary LD Premounted Stent System and Express…Summary page 1…LD Biliary Premounted Stent System has the same intended use and device performance as the predicates Express LID Biliary Premounted Stent System (K021630, K024048, and K032360). Boston Scientific Corporation Confidential Attachment 5 - Page 1of 3… | 2003 |
| † | K100892 | Renegade HI-Flo Fathom Kit Model M001182XXX | 2010 |
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 23 years and passes through 6 companies; a new generation was cleared every 5 months on median.
- None of the 16 ancestors has a recall.
- 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. 2014, 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 Express LD Biliary Premounted Stent System is indicated for the palliation of
malignant neoplasms in the biliary tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133110 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133110: Express LD Biliary Premounted 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/K133110
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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