510(k) · Decided
Recalled · Class II · 2022Cordis Palmaz Genesis Transhepatic Billary Stent on Opta Pro .035 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 Dec 22, 2003 as substantially equivalent to K012590 (Cordis Corp., 2001) after a 60-day review. Its family tree reaches back 7 generations to 1991. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 22, 2003
- Review
- 60 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K905720 (1991). 14 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK905720 Palmaz Biliary StentJohnson & Johnson Interventional Systems · 1991
- 6 generations backK990631 Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis Corp. · 1999
- 5 generations backK991028 Cordis Palmaz Corinthian Transhepatic Biliary Stent and AccessoriesCordis Corp. · 1999
- 4 generations backK992755 Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis, A Johnson & Johnson Co. · 1999
- 3 generations backK994156 Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary…Cordis Corp. · 2000
- 2 generations backK012056 Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018…Cordis Europa, N.V. · 2001
- 1 generation backK012590 Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035…Cordis Corp. · 2001
- This deviceK033394 Cordis Palmaz Genesis Transhepatic Billary Stent on Opta Pro .035…Cordis Corp. · 2003
- Descendant · cites it directly · 0 of its ownK092352 Scuba Biliary Stent SystemInvatec S.P.A. · 2010
Most influential descendants
Showing 1 of 1 · See all- K092352Scuba Biliary Stent SystemInvatec S.P.A. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K905720 | Palmaz Biliary Stent | Johnson & Johnson Interventional Systems | 1991 | — |
| −6 | K990631 | Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model… | Cordis Corp. | 1999 | — |
| −5 | K991028 | Cordis Palmaz Corinthian Transhepatic Biliary Stent and Accessories | Cordis Corp. | 1999 | — |
| −4 | K992755 | Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System… | Cordis, A Johnson & Johnson Co. | 1999 | — |
| −3 | K994156 | Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary Stent, Models… | Cordis Corp. | 2000 | — |
| −2 | 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 | — |
| 0 (this device) | K033394 | Cordis Palmaz Genesis Transhepatic Billary Stent on Opta Pro .035 Delivery… | Cordis Corp. | 2003 | — |
| +1 | K092352 | Scuba Biliary Stent System | Invatec S.P.A. | 2010 | — |
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 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K012590 | Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035 Delivery SystemSummary page 1…n to the original Cordis premounted PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System (ref. 510(k) #K012590) with no change to the indication for use or to the fundamental scientific technology of the predecessor de… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092352 | Scuba Biliary Stent System | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 20, 2022 | Class II | Z-1363-2022 | Process design | Potential for stent dislodgement and associated failures related to two specific sizes of the 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 4 companies; a new generation was cleared every 4 months on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K092352 (Invatec S.P.A., 2010) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K012590.
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® GENESISTM Transhepatic Biliary Stent on OPTA PRO .035" Delivery System 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/K033394 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033394: Cordis Palmaz Genesis Transhepatic Billary Stent on Opta Pro .035 Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033394
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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