510(k) Report

510(k) · Decided

Decided

Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035 Delivery System

K012590510(k) SpecialDecided Sep 7, 200128-day reviewClass II21 CFR 876.5010

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cordis Corp. · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on Sep 7, 2001 as substantially equivalent to K012090 (Cordis, A Johnson & Johnson Co., 2001) and 4 other predicates after a 28-day review. Its family tree reaches back 6 generations to 1991. 5 later devices descend from it.

Decided
Sep 7, 2001
Review
28 days
Class
Class II
Product code
FGE
Recalls
None
Predicates
5

Its longest line of descent runs back 6 generations to K905720 (1991). 13 ancestors in all. 5 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1998: 1 other ancestor1997: 2 other ancestors2000: 2 other ancestors1991: 1 other ancestor2003: 1 descendant cleared2002: 1 descendant cleared2010: 1 descendant cleared2004: 2 descendants clearedK905720 · Palmaz Biliary Stent · Johnson & Johnson Interventional Systems · 1991×4: 4 generations cleared close together, K990631 (1999), K991028 (1999), K992755 (1999), K994156 (2000) K012056 · Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery System · Cordis Europa, N.V. · 20011990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 4 other ancestors 1 generation forward: 4 descendants2 generations forward: 1 descendant K012056 · Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery System · Cordis Europa, N.V. · 2001K994156 · Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary Stent, Models PQ294B, PQ394B · Cordis Corp. · 2000K992755 · Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Cordis Crimping Tools, Cordis Introducer Tube · Cordis, A Johnson & Johnson Co. · 1999K991028 · Cordis Palmaz Corinthian Transhepatic Biliary Stent and Accessories · Cordis Corp. · 1999K990631 · Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC · Cordis Corp. · 1999K905720 · Palmaz Biliary Stent · Johnson & Johnson Interventional Systems · 1991−50
  1. Root · 6 generations backK905720 Palmaz Biliary StentJohnson & Johnson Interventional Systems · 1991
  2. 5 generations backK990631 Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis Corp. · 1999
  3. 4 generations backK991028 Cordis Palmaz Corinthian Transhepatic Biliary Stent and AccessoriesCordis Corp. · 1999
  4. 3 generations backK992755 Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis, A Johnson & Johnson Co. · 1999
  5. 2 generations backK994156 Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary…Cordis Corp. · 2000
  6. 1 generation backK012056 Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018…Cordis Europa, N.V. · 2001
  7. This deviceK012590 Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035…Cordis Corp. · 2001
  8. Descendant · cites it directly · 1 of its ownK033909 Wavemax Balloon-Expandable Transhepatic Biliary Stent SystemAbbott Laboratories · 2004
  9. Descendant · cites it directly · 1 of its ownK033394 Cordis Palmaz Genesis Transhepatic Billary Stent on Opta Pro .035…Cordis Corp. · 2003 · Recalled
  10. Descendant · cites it directly · 0 of its ownK092352 Scuba Biliary Stent SystemInvatec S.P.A. · 2010
  11. Descendant · 2 generations on · 0 of its ownK041962 Xpand Balloon-Expandable Transhepatic Biliary Stent System, Models…Abbott Laboratories · 2004
  12. Descendant · cites it directly · 0 of its ownK020809 Modification to Cordis Palmaz Genesis Transhepatic Biliary StentCordis Corp. · 2002

Most influential descendants

Showing 5 of 5 · See all
  • K033909Wavemax Balloon-Expandable Transhepatic Biliary Stent SystemAbbott Laboratories · 2004 · cites it directly1descendant
  • K033394Cordis Palmaz Genesis Transhepatic Billary Stent on Opta Pro .035 Delivery SystemCordis Corp. · 2003 · cites it directly1descendant
  • K092352Scuba Biliary Stent SystemInvatec S.P.A. · 2010 · cites it directly0descendants
  • K041962Xpand Balloon-Expandable Transhepatic Biliary Stent System, Models 20587, 20588, 20589…Abbott Laboratories · 2004 · 2 generations on0descendants
  • K020809Modification to Cordis Palmaz Genesis Transhepatic Biliary StentCordis Corp. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K905720Palmaz Biliary StentJohnson & Johnson Interventional Systems1991—
−5K990631Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model…Cordis Corp.1999—
−4K991028Cordis Palmaz Corinthian Transhepatic Biliary Stent and AccessoriesCordis Corp.1999—
−3K992755Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System…Cordis, A Johnson & Johnson Co.1999—
−2K994156Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary Stent, Models…Cordis Corp.2000—
−1K012056Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery SystemCordis Europa, N.V.2001—
0 (this device)K012590Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035 Delivery…Cordis Corp.2001—
+1K033909Wavemax Balloon-Expandable Transhepatic Biliary Stent SystemAbbott Laboratories2004—
+1K033394Cordis Palmaz Genesis Transhepatic Billary Stent on Opta Pro .035 Delivery…Cordis Corp.20031
+1K092352Scuba Biliary Stent SystemInvatec S.P.A.2010—
+2K041962Xpand Balloon-Expandable Transhepatic Biliary Stent System, Models 20587…Abbott Laboratories2004—
+1K020809Modification to Cordis Palmaz Genesis Transhepatic Biliary StentCordis Corp.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199720
199810
200020
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200420
201010
FIG. 1 — Lineage of K012590, 1991–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 13 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K012090Cordis Palmaz Genesis Transhepatic Biliary StentCordis, A Johnson & Johnson Co.2001—
*K012056Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery System
Summary page 1
…LMAZ® GENESIS™ Transhepatic Biliary Stent (ref. KO12090) pre(_ilcate e Cordis PALMAZ® GENESIS ™ Transhepatic Biliary Stent on SLALOM .018 device(s) Delivery System (ref. K012056) e Cordis OPTA ™ PRO (formerly known as OPTA LP) PTA Balloon Catheter (ref. K971448, K981407, K991028) 1 Cordis…
Cordis Europa, N.V.2001—
*K971448Cordis Opta LP Pta Balloon Catheter
Summary page 1
…GENESIS ™ Transhepatic Biliary Stent on SLALOM .018 device(s) Delivery System (ref. K012056) e Cordis OPTA ™ PRO (formerly known as OPTA LP) PTA Balloon Catheter (ref. K971448, K981407, K991028) 1 Cordis Europa N.V., Special 510(k) Premarket Notification a Johnson & Johnson company Perf…
Cordis Corp.1997—
*K981407Opta LP Pta Balloon Catheter/Powerflex Plus Pta Balloon Catheter
Summary page 1
…™ Transhepatic Biliary Stent on SLALOM .018 device(s) Delivery System (ref. K012056) e Cordis OPTA ™ PRO (formerly known as OPTA LP) PTA Balloon Catheter (ref. K971448, K981407, K991028) 1 Cordis Europa N.V., Special 510(k) Premarket Notification a Johnson & Johnson company Performance s…
Cordis Corp.1998—
*K991028Cordis Palmaz Corinthian Transhepatic Biliary Stent and Accessories
Summary page 1
…patic Biliary Stent on SLALOM .018 device(s) Delivery System (ref. K012056) e Cordis OPTA ™ PRO (formerly known as OPTA LP) PTA Balloon Catheter (ref. K971448, K981407, K991028) 1 Cordis Europa N.V., Special 510(k) Premarket Notification a Johnson & Johnson company Performance standards…
Cordis Corp.1999—

Also cleared against K012090: 1 other device →

What descends from it? (5)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K033909Wavemax Balloon-Expandable Transhepatic Biliary Stent SystemAbbott Laboratories20041
K033394Cordis Palmaz Genesis Transhepatic Billary Stent on Opta Pro .035 Delivery SystemCordis Corp.20031
K092352Scuba Biliary Stent SystemInvatec S.P.A.20100
K020809Modification to Cordis Palmaz Genesis Transhepatic Biliary StentCordis Corp.20020

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 13 ancestors has a recall.
  • Of its descendants, K033909 (Abbott Laboratories, 2004) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K012090.

How does its category compare?

All FGE devices

FGE 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

2007: 42008: 112009: 72010: 92011: 92012: 82013: 52014: 82015: 82016: 42017: 92018: 72019: 22020: 42021: 12022: 62023: 62024: 62025: 72026 (partial year): 8
2007high 11 (2008) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FGE

257in 2025

2007: 316 days median2008: 214 days median2009: 160 days median2010: 81 days median2011: 114 days median2012: 96 days median2013: 161 days median2014: 156 days median2015: 79 days median2016: 49 days median2017: 59 days median2018: 215 days median2020: 121 days median2022: 101 days median2023: 199 days median2024: 188 days median2025: 257 days median2026 (partial year): 153 days median
2007high 316 (2007) · low 49 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FGE

1in 2024

2007: 542008: 932009: 182010: 322011: 22012: 42013: 32017: 12018: 432019: 132020: 12021: 272022: 212023: 192024: 12026 (partial year): 11
2007high 93 (2008) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FGE

1,923in 2025

2007: 1,0062008: 1,4652009: 1,6552010: 1,4342011: 1,3212012: 1,1832013: 1,0602014: 1,2702015: 1,5432016: 1,4532017: 1,5152018: 1,6812019: 1,8962020: 2,1822021: 2,2972022: 1,7492023: 1,6152024: 1,9482025: 1,923
2007high 2,297 (2021) · low 1,006 (2007)2025

MAUDE reports naming product code FGE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074316541,006
200811214931,465
20097160181,655
2010981321,434
2011911421,321
201289641,183
2013516131,060
2014815601,270
201587901,543
201644901,453
201795911,515
20187215431,681
20192—131,896
2020412112,182
20211—272,297
20226101211,749
20236199191,615
2024618811,948
2025725701,923
2026815311—

What is it indicated for?

The Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on OPTA™ PRO .035” 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.

Also cleared against K012090

1 other device cites the same predicate.

  • K020809Modification to Cordis Palmaz Genesis Transhepatic Biliary StentCordis Corp. · 2002

More from Cordis Corp.

551 FDA decisions under this applicant name. See the company

  • P020026/S086Cypher Sirolimus-Eluting Coronary StentCordis Corp. · 2014
  • K130981Flexstent Biliary Self Expanding Stent System; S.M.a.R.T. RE-Flex Biliary Elf-Expanding Stent SystemCordis Corp. · 2014
  • K112797Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corp. · 2012
  • P020026/S082Cypher Sirolimus-Eluting Coronary StentCordis Corp. · 2012
  • P020026/S085Cypher Sirolimus-Eluting Coronary StentCordis Corp. · 2012

Recent decisions in FGE

The FGE category page

  • K254179Drainage CatheterCanyon Medical, Inc. · 2026
  • K262913Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemMedtronic, Inc. · 2026
  • K260835ARCHIMEDES Biodegradable Stent (Medium)Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) · 2026
  • K253393Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019…Hangzhou AGS MedTech Co., Ltd. · 2026
  • K253832Dilation Balloon CatheterMirco-Tech (Nanjing) Co., Ltd. · 2026

https://510kreport.com/device/K012590 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012590: Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035 Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012590

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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