510(k) Report

510(k) · Cleared

Cleared

Palmaz (TM) Balloon-Expandable Stent, Modification

K911581510(k) TraditionalCleared Jun 4, 199156-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

Johnson & Johnson Interventional Systems · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on Jun 4, 1991 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 36 later devices descend from it.

Decided
Jun 4, 1991
Review
56 days
Class
Class II
Product code
FGE
Recalls
None
Predicates
0

36 later devices descend from it, 12 citing it directly.

Descendants, by year cleared 1999: 11 descendants cleared1998: 2 descendants cleared2002: 3 descendants cleared1996: 1 descendant cleared2000: 2 descendants cleared2001: 4 descendants cleared2006: 3 descendants cleared2003: 4 descendants cleared2010: 1 descendant cleared2004: 3 descendants cleared2014: 1 descendant cleared2007: 1 descendant cleared1990200020102020
  1. This deviceK911581 Palmaz (TM) Balloon-Expandable Stent, ModificationJohnson & Johnson Interventional Systems · 1991
  2. Descendant · cites it directly · 21 of its ownK990631 Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis Corp. · 1999
  3. Descendant · cites it directly · 19 of its ownK991028 Cordis Palmaz Corinthian Transhepatic Biliary Stent and AccessoriesCordis Corp. · 1999
  4. Descendant · 2 generations on · 17 of its ownK992755 Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis, A Johnson & Johnson Co. · 1999
  5. Descendant · 3 generations on · 11 of its ownK994156 Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary…Cordis Corp. · 2000
  6. Descendant · 3 generations on · 9 of its ownK012056 Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018…Cordis Europa, N.V. · 2001

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

1996: 11998: 21999: 112000: 22001: 42002: 32003: 42004: 32006: 32007: 12010: 12014: 1
1996high 11 (1999) · low 0 (1997)2026

Most influential descendants

Showing 5 of 36 · See all
  • K990631Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model PC125BPS…Cordis Corp. · 1999 · cites it directly21descendants
  • K991028Cordis Palmaz Corinthian Transhepatic Biliary Stent and AccessoriesCordis Corp. · 1999 · cites it directly19descendants
  • K992755Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Cordis Crimping…Cordis, A Johnson & Johnson Co. · 1999 · 2 generations on17descendants
  • K994156Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary Stent, Models PQ294B…Cordis Corp. · 2000 · 3 generations on11descendants
  • K012056Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery SystemCordis Europa, N.V. · 2001 · 3 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K911581Palmaz (TM) Balloon-Expandable Stent, ModificationJohnson & Johnson Interventional Systems1991—
+1K990631Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model…Cordis Corp.1999—
+1K991028Cordis Palmaz Corinthian Transhepatic Biliary Stent and AccessoriesCordis Corp.1999—
+2K992755Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System…Cordis, A Johnson & Johnson Co.1999—
+3K994156Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary Stent, Models…Cordis Corp.2000—
+3K012056Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery SystemCordis Europa, N.V.2001—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199820
1999110
200020
200140
200230
200340
200430
200630
200710
201010
201410
FIG. 1 — Lineage of K911581, 1991–2014Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (36)

See all 36

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

NumberDeviceApplicantDecidedDescendants
K990631Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model PC125BPS…Cordis Corp.199921
K991028Cordis Palmaz Corinthian Transhepatic Biliary Stent and AccessoriesCordis Corp.199919
K955728Cordis Biliary StentCordis Corp.19968
K980653Perflex Stainless Steel Stent and Delivery SystemCordis Corp.19987
K983075Guidant Megalink Biliary Stent, Model #'S 1002949-18, 1002949-28, 1002949-38Guidant Corp.19994
K980290Iti StentIntratherapeutics, Inc.19984
K991929IntrastentIntratherapeutics, Inc.19993
K992319RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent SystemGuidant Corp.19992
K993904Intrastent Doublestrut LDIntratherapeutics, Inc.20001
K990867RX Herculink 14 Biliary Stent System, Model…Advanced Cardiovascular Systems, Inc.19991

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, K990631 (Cordis Corp., 1999) has gone furthest, with 21 descendants of its own.

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—

More from Johnson & Johnson Interventional Systems

2 FDA decisions under this applicant name. See the company

  • K905720Palmaz Biliary StentJohnson & Johnson Interventional Systems · 1991

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https://510kreport.com/device/K911581 · printed Nov 6, 2026

Cite this page

510(k) Report. “K911581: Palmaz (TM) Balloon-Expandable Stent, Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K911581

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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