510(k) Report

510(k) · Decided

Decided

Cordis Palmaz Genesis Transhepatic Biliary Stent

K012090510(k) SpecialDecided Aug 1, 200127-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, A Johnson & Johnson Co. · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on Aug 1, 2001 as substantially equivalent to K001258 (Cordis Corp., 2000) and 1 other predicate after a 27-day review. Its family tree reaches back 3 generations to 1991. 6 later devices descend from it.

Decided
Aug 1, 2001
Review
27 days
Class
Class II
Product code
FGE
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K905720 (1991). 8 ancestors in all. 6 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1998: 1 other ancestor1997: 2 other ancestors1991: 1 other ancestor2002: 1 descendant cleared2001: 1 descendant cleared2003: 1 descendant cleared2010: 1 descendant cleared2004: 2 descendants clearedK905720 · Palmaz Biliary Stent · Johnson & Johnson Interventional Systems · 1991×2: 2 generations cleared close together, K990631 (1999), K991028 (1999) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 4 other ancestors 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant K991028 · 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 · 19910
  1. Root · 3 generations backK905720 Palmaz Biliary StentJohnson & Johnson Interventional Systems · 1991
  2. 2 generations backK990631 Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis Corp. · 1999
  3. 1 generation backK991028 Cordis Palmaz Corinthian Transhepatic Biliary Stent and AccessoriesCordis Corp. · 1999
  4. This deviceK012090 Cordis Palmaz Genesis Transhepatic Biliary StentCordis, A Johnson & Johnson Co. · 2001
  5. Descendant · cites it directly · 5 of its ownK012590 Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035…Cordis Corp. · 2001
  6. Descendant · 2 generations on · 1 of its ownK033909 Wavemax Balloon-Expandable Transhepatic Biliary Stent SystemAbbott Laboratories · 2004
  7. Descendant · 2 generations on · 1 of its ownK033394 Cordis Palmaz Genesis Transhepatic Billary Stent on Opta Pro .035…Cordis Corp. · 2003 · Recalled
  8. Descendant · 2 generations on · 0 of its ownK092352 Scuba Biliary Stent SystemInvatec S.P.A. · 2010
  9. Descendant · 3 generations on · 0 of its ownK041962 Xpand Balloon-Expandable Transhepatic Biliary Stent System, Models…Abbott Laboratories · 2004

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2001: 12002: 12003: 12004: 22010: 1
2001high 2 (2004) · low 0 (2005)2026

Most influential descendants

Showing 5 of 6 · See all
  • K012590Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035 Delivery SystemCordis Corp. · 2001 · cites it directly5descendants
  • 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
  • K092352Scuba Biliary Stent SystemInvatec S.P.A. · 2010 · 2 generations on0descendants
  • K041962Xpand Balloon-Expandable Transhepatic Biliary Stent System, Models 20587, 20588, 20589…Abbott Laboratories · 2004 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K905720Palmaz Biliary StentJohnson & Johnson Interventional Systems1991—
−2K990631Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model…Cordis Corp.1999—
−1K991028Cordis Palmaz Corinthian Transhepatic Biliary Stent and AccessoriesCordis Corp.1999—
0 (this device)K012090Cordis Palmaz Genesis Transhepatic Biliary StentCordis, A Johnson & Johnson Co.2001—
+1K012590Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035 Delivery…Cordis Corp.2001—
+2K033909Wavemax Balloon-Expandable Transhepatic Biliary Stent SystemAbbott Laboratories2004—
+2K033394Cordis Palmaz Genesis Transhepatic Billary Stent on Opta Pro .035 Delivery…Cordis Corp.20031
+2K092352Scuba Biliary Stent SystemInvatec S.P.A.2010—
+3K041962Xpand Balloon-Expandable Transhepatic Biliary Stent System, Models 20587…Abbott Laboratories2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199720
199810
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
200310
200420
201010
FIG. 1 — Lineage of K012090, 1991–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (2)

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
*K001258BX Transhepatic Biliary Stent and Delivery System
Summary page 1
…ESIS Transhepatic Biliary Stent are substantially equivalent to those featured with the predecessor Cordis BX Transhepatic Biliary Stent and Delivery System (see 510(k) #K001258). In short, the subject Cordis PALMAZ GENESIS Transhepatic Biliary Stent represents an unmounted (provided separately from its de…
Cordis Corp.2000—
*K991028Cordis Palmaz Corinthian Transhepatic Biliary Stent and Accessories
Summary page 2
…d with the predicate Cordis BX Transhepatic Biliary Stent and Delivery System (see 510(k) #K001258) and Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stents (see 510(k) #K991028). The PALMAZ GENESIS Transhepatic Biliary Stent is provided in nominal unexpanded lengths of 29-79 mm and is designed for expande…
Cordis Corp.1999—

Also cleared against K001258: 2 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K012590Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035 Delivery SystemCordis Corp.20015
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 3 companies; a new generation was cleared every 2.0 years on median.
  • None of the 8 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 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 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 K001258

2 other devices cite the same predicate.

  • K012087Cordis Palmaz Genesis Transhepatic Biliary StentCordis Corp. · 2001
  • K012056Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery SystemCordis Europa, N.V. · 2001

More from Cordis, A Johnson & Johnson Co.

4 FDA decisions under this applicant name. See the company

  • K140286Optease Vena Cava Filter and Optease Retrieval CathteterCordis, A Johnson & Johnson Co. · 2014
  • K013581Cordis Aviator Peripheral Dilatation CatheterCordis, A Johnson & Johnson Co. · 2001
  • K992755Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Cordis Crimping Tools, Cordis…Cordis, A Johnson & Johnson Co. · 1999

Recent decisions in FGE

The FGE category page

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  • 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/K012090 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012090: Cordis Palmaz Genesis Transhepatic Biliary Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012090

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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