510(k) · Decided
DecidedBX Transhepatic Biliary Stent and Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Corp. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Jun 27, 2000 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- Jun 27, 2000
- Review
- 70 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 3 citing it directly.
- This deviceK001258 BX Transhepatic Biliary Stent and Delivery SystemCordis Corp. · 2000
- Descendant · cites it directly · 9 of its ownK012056 Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018…Cordis Europa, N.V. · 2001
- Descendant · cites it directly · 6 of its ownK012090 Cordis Palmaz Genesis Transhepatic Biliary StentCordis, A Johnson & Johnson Co. · 2001
- Descendant · 2 generations on · 5 of its ownK012590 Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035…Cordis Corp. · 2001
- Descendant · 2 generations on · 2 of its ownK040413 Cordis Palmaz Blue Transhepatic Biliary Stent on Slalom .018…Cordis Europa, N.V. · 2004
- Descendant · 3 generations on · 1 of its ownK053454 RX Herculink Elite Biliary Stent SystemGuidant Corporation · 2006
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K012056Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery SystemCordis Europa, N.V. · 2001 · cites it directly9descendants
- K012090Cordis Palmaz Genesis Transhepatic Biliary StentCordis, A Johnson & Johnson Co. · 2001 · cites it directly6descendants
- K012590Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035 Delivery SystemCordis Corp. · 2001 · 2 generations on5descendants
- K040413Cordis Palmaz Blue Transhepatic Biliary Stent on Slalom .018 Delivery SystemCordis Europa, N.V. · 2004 · 2 generations on2descendants
- K053454RX Herculink Elite Biliary Stent SystemGuidant Corporation · 2006 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001258 | BX Transhepatic Biliary Stent and Delivery System | Cordis Corp. | 2000 | — |
| +1 | K012056 | Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery System | Cordis Europa, N.V. | 2001 | — |
| +1 | K012090 | Cordis Palmaz Genesis Transhepatic Biliary Stent | Cordis, A Johnson & Johnson Co. | 2001 | — |
| +2 | K012590 | Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035 Delivery… | Cordis Corp. | 2001 | — |
| +2 | K040413 | Cordis Palmaz Blue Transhepatic Biliary Stent on Slalom .018 Delivery System | Cordis Europa, N.V. | 2004 | — |
| +3 | K053454 | RX Herculink Elite Biliary Stent System | Guidant Corporation | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (12)
See all 123 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K012056 (Cordis Europa, N.V., 2001) has gone furthest, with 9 descendants of its own.
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 | — |
https://510kreport.com/device/K001258 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001258: BX Transhepatic Biliary Stent and Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001258
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026