510(k) · Decided
DecidedBoston Scientific Express Biliary LD Premounted Stent System
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 Oct 25, 2002 as substantially equivalent to K992755 (Cordis, A Johnson & Johnson Co., 1999) and 2 other predicates after a 161-day review. Its family tree reaches back 4 generations to 1991. 4 later devices descend from it.
- Decided
- Oct 25, 2002
- Review
- 161 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K905720 (1991). 12 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK905720 Palmaz Biliary StentJohnson & Johnson Interventional Systems · 1991
- 3 generations backK990631 Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis Corp. · 1999
- 2 generations backK991028 Cordis Palmaz Corinthian Transhepatic Biliary Stent and AccessoriesCordis Corp. · 1999
- 1 generation backK992755 Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis, A Johnson & Johnson Co. · 1999
- This deviceK021630 Boston Scientific Express Biliary LD Premounted Stent SystemBoston Scientific Corp · 2002
- Descendant · cites it directly · 3 of its ownK024048 Modification to Boston Scientific Express Biliary LD Premounted…Boston Scientific Scimed, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK030645 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 · cites it directly · 0 of its ownK133110 Express LD Biliary Premounted Stent SystemBoston Scientific Corporation · 2014
Most influential descendants
Showing 4 of 4 · See all- K024048Modification to Boston Scientific Express Biliary LD Premounted Stent SystemBoston Scientific Scimed, Inc. · 2003 · cites it directly3descendants
- K030645Boston Scientific Express Biliary LD Unmounted StentBoston Scientific Corp · 2003 · cites it directly2descendants
- K032360Modification to Boston Scientific Express Biliary LD Premounted Stent System and Express…Boston Scientific Corp · 2003 · cites it directly1descendant
- K133110Express LD Biliary Premounted Stent SystemBoston Scientific Corporation · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K905720 | Palmaz Biliary Stent | Johnson & Johnson Interventional Systems | 1991 | — |
| −3 | K990631 | Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model… | Cordis Corp. | 1999 | — |
| −2 | K991028 | Cordis Palmaz Corinthian Transhepatic Biliary Stent and Accessories | Cordis Corp. | 1999 | — |
| −1 | K992755 | Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System… | Cordis, A Johnson & Johnson Co. | 1999 | — |
| 0 (this device) | 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 | — |
| +1 | 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 | — |
| +1 | 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 | 3 | 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? (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 |
|---|---|---|---|
| * | K992755 | Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Cordis Crimping…Summary page 1…ice Description Stent The Express Biliary LD stent will be substantially equivalent to the legally marketed Johnson & Johnson Corinthian IQ Transhepatic Biliary Stent (K992755). The Express Biliary LD Stent is a balloon expandable metallic stent intended to maintain patency of biliary strictures produce… | 1999 |
| * | K011889 | Ultra -Thin SDS Balloon Dilatation Catheter | 2001 |
| * | K011909 | Ultra-Thin SDS Balloon Dilatation Catheter | 2001 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024048 | Modification to Boston Scientific Express Biliary LD Premounted Stent System | 2003 | 3 |
| K030645 | Boston Scientific Express Biliary LD Unmounted Stent | 2003 | 2 |
| K032360 | Modification to Boston Scientific Express Biliary LD Premounted Stent System and Express… | 2003 | 1 |
| K133110 | Express LD Biliary Premounted Stent System | 2014 | 0 |
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 11 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K024048 (Boston Scientific Scimed, Inc., 2003) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K992755.
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 Premounted Stent System is intended for the palliation of malignant neoplasms in the biliary tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021630 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021630: Boston Scientific Express Biliary LD Premounted Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021630
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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