510(k) · Decided
DecidedCordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Europa, N.V. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Aug 1, 2001 as substantially equivalent to K001258 (Cordis Corp., 2000) and 3 other predicates after a 30-day review. Its family tree reaches back 5 generations to 1991. 9 later devices descend from it.
- Decided
- Aug 1, 2001
- Review
- 30 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K905720 (1991). 11 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK905720 Palmaz Biliary StentJohnson & Johnson Interventional Systems · 1991
- 4 generations backK990631 Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis Corp. · 1999
- 3 generations backK991028 Cordis Palmaz Corinthian Transhepatic Biliary Stent and AccessoriesCordis Corp. · 1999
- 2 generations backK992755 Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis, A Johnson & Johnson Co. · 1999
- 1 generation backK994156 Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary…Cordis Corp. · 2000
- This deviceK012056 Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018…Cordis Europa, N.V. · 2001
- Descendant · cites it directly · 5 of its ownK012590 Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035…Cordis Corp. · 2001
- Descendant · cites it directly · 2 of its ownK040413 Cordis Palmaz Blue Transhepatic Biliary Stent on Slalom .018…Cordis Europa, N.V. · 2004
- Descendant · 2 generations on · 1 of its ownK053454 RX Herculink Elite Biliary Stent SystemGuidant Corporation · 2006
- Descendant · 2 generations on · 1 of its ownK033909 Wavemax Balloon-Expandable Transhepatic Biliary Stent SystemAbbott Laboratories · 2004
- Descendant · 2 generations on · 1 of its ownK033394 Cordis Palmaz Genesis Transhepatic Billary Stent on Opta Pro .035…Cordis Corp. · 2003 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K012590Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035 Delivery SystemCordis Corp. · 2001 · cites it directly5descendants
- K040413Cordis Palmaz Blue Transhepatic Biliary Stent on Slalom .018 Delivery SystemCordis Europa, N.V. · 2004 · cites it directly2descendants
- K053454RX Herculink Elite Biliary Stent SystemGuidant Corporation · 2006 · 2 generations on1descendant
- K033909Wavemax Balloon-Expandable Transhepatic Biliary Stent SystemAbbott Laboratories · 2004 · 2 generations on1descendant
- K033394Cordis Palmaz Genesis Transhepatic Billary Stent on Opta Pro .035 Delivery SystemCordis Corp. · 2003 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K905720 | Palmaz Biliary Stent | Johnson & Johnson Interventional Systems | 1991 | — |
| −4 | K990631 | Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model… | Cordis Corp. | 1999 | — |
| −3 | K991028 | Cordis Palmaz Corinthian Transhepatic Biliary Stent and Accessories | Cordis Corp. | 1999 | — |
| −2 | K992755 | Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System… | Cordis, A Johnson & Johnson Co. | 1999 | — |
| −1 | K994156 | Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary Stent, Models… | Cordis Corp. | 2000 | — |
| 0 (this device) | K012056 | Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery System | Cordis Europa, N.V. | 2001 | — |
| +1 | K012590 | Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035 Delivery… | Cordis Corp. | 2001 | — |
| +1 | K040413 | Cordis Palmaz Blue Transhepatic Biliary Stent on Slalom .018 Delivery System | Cordis Europa, N.V. | 2004 | — |
| +2 | K053454 | RX Herculink Elite Biliary Stent System | Guidant Corporation | 2006 | — |
| +2 | K033909 | Wavemax Balloon-Expandable Transhepatic Biliary Stent System | Abbott Laboratories | 2004 | — |
| +2 | K033394 | Cordis Palmaz Genesis Transhepatic Billary Stent on Opta Pro .035 Delivery… | Cordis Corp. | 2003 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 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), 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? (4)
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 |
|---|---|---|---|
| * | K001258 | BX Transhepatic Biliary Stent and Delivery SystemSummary page 1…e: Biliary stent and accessories Classification Name: 21 CFR 876.5010 Biliary Catheter. Class |l. > Condis BX Transhepatic Biliary Stent and Delivery System (reference K001258) » Cordis PALMAZ CORINTHIAN 1Q Transhepatic Biliary Stent and Delivery System (ref. K992755 and K994156) » Cordis SLALOM PTA Ba… | 2000 |
| * | K992755 | Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Cordis Crimping…Summary page 1…s |l. > Condis BX Transhepatic Biliary Stent and Delivery System (reference K001258) » Cordis PALMAZ CORINTHIAN 1Q Transhepatic Biliary Stent and Delivery System (ref. K992755 and K994156) » Cordis SLALOM PTA Balloon Catheter (ref. KO03159) Pase e Cordis Europa N.V., Special 510(k) Prem… | 1999 |
| * | K994156 | Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary Stent, Models PQ294B…Summary page 1…dis BX Transhepatic Biliary Stent and Delivery System (reference K001258) » Cordis PALMAZ CORINTHIAN 1Q Transhepatic Biliary Stent and Delivery System (ref. K992755 and K994156) » Cordis SLALOM PTA Balloon Catheter (ref. KO03159) Pase e Cordis Europa N.V., Special 510(k) Premarket Notifi… | 2000 |
| * | K003159 | Cordis Slalom Pta Balloon CatheterSummary page 2…ic Biliary Stent on SLALOM .018" Delivery System is a balloon-expandable, stainless steel stent that is provided premounted upon the Cordis SLALOM balloon catheter (ref. K003159). The stent is provided in four nominal, unexpanded stent lengths: 12, 15, 18 & 24 mm. The stent is designed for expansion to dia… | 2000 |
What descends from it? (9)
2 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?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 4 months on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K012590 (Cordis Corp., 2001) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K001258.
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 Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on SLALOM™ .01 8” Delivery System is indicated for the palliation of malignant neoplasms in the biliary tree.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012056 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012056: Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 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/K012056
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026