510(k) Report

510(k) · Decided

Decided

Modification to Smart Control Nitinol Stent Transhepatic Biliary System

K032457510(k) SpecialDecided Sep 4, 200324-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 4, 2003 as substantially equivalent to K021898 (Cordis Corp., 2002) and 1 other predicate after a 24-day review. Its family tree reaches back 4 generations to 2001. 9 later devices descend from it.

Decided
Sep 4, 2003
Review
24 days
Class
Class II
Product code
FGE
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K010445 (2001). 9 ancestors in all, the oldest K971010 (1997). 9 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2001: 1 other ancestor2000: 1 other ancestor1999: 1 other ancestor1997: 1 other ancestor2004: 1 descendant cleared2006: 1 descendant cleared2008: 2 descendants cleared2010: 1 descendant cleared2012: 2 descendants cleared2011: 1 descendant cleared2013: 1 descendant clearedK010445 · Precise Nitinol Stent Transhepatic Billary System · Cordis Corp. · 2001K012993 · Modification to Precise Nitinol Stent Transhepatic Biliary System · Cordis Corp. · 2001 · recalledK021898 · Smart Control Nitinol Stent Transhepatic Biliary System · Cordis Corp. · 2002 · recalledK031777 · Modeification to: Smart Control Nitinol Stent Transhepatic Biliary System · Cordis Corp. · 2003 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 5 other ancestors 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K031777 · Modeification to: Smart Control Nitinol Stent Transhepatic Biliary System · Cordis Corp. · 2003 · recalledK021898 · Smart Control Nitinol Stent Transhepatic Biliary System · Cordis Corp. · 2002 · recalledK012993 · Modification to Precise Nitinol Stent Transhepatic Biliary System · Cordis Corp. · 2001 · recalledK010445 · Precise Nitinol Stent Transhepatic Billary System · Cordis Corp. · 20010
  1. Root · 4 generations backK010445 Precise Nitinol Stent Transhepatic Billary SystemCordis Corp. · 2001
  2. 3 generations backK012993 Modification to Precise Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 2001 · Recalled
  3. 2 generations backK021898 Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 2002 · Recalled
  4. 1 generation backK031777 Modeification to: Smart Control Nitinol Stent Transhepatic Biliary…Cordis Corp. · 2003 · Recalled
  5. This deviceK032457 Modification to Smart Control Nitinol Stent Transhepatic Biliary…Cordis Corp. · 2003
  6. Descendant · cites it directly · 6 of its ownK060557 Suresave TM Self-Expandable Nitinol Stent and Precision TM Delivery…Idev Technologies, Inc. · 2006
  7. Descendant · 2 generations on · 5 of its ownK071646 Supera Interwoven Self-Expanding Biliary Nitinol Stent Delivery…Idev Technologies, Inc. · 2008
  8. Descendant · 2 generations on · 4 of its ownK093893 Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic…Idev Technologies, Inc. · 2010 · Recalled
  9. Descendant · cites it directly · 4 of its ownK062798 Smart Nitinol Self-Expanding Stent, Model C06120MB, C07120MB…Cordis Corp. · 2008 · Recalled
  10. Descendant · 2 generations on · 2 of its ownK111766 Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic…Idev Technologies, Inc. · 2011 · Recalled

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2004: 12006: 12008: 22010: 12011: 12012: 22013: 1
2004high 2 (2008) · low 0 (2005)2026

Most influential descendants

Showing 5 of 9 · See all
  • K060557Suresave TM Self-Expandable Nitinol Stent and Precision TM Delivery Catheter-SS06120060Idev Technologies, Inc. · 2006 · cites it directly6descendants
  • K071646Supera Interwoven Self-Expanding Biliary Nitinol Stent Delivery Catheter, Model #…Idev Technologies, Inc. · 2008 · 2 generations on5descendants
  • K093893Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemIdev Technologies, Inc. · 2010 · 2 generations on4descendants
  • K062798Smart Nitinol Self-Expanding Stent, Model C06120MB, C07120MB, C08120MB, C06150MB…Cordis Corp. · 2008 · cites it directly4descendants
  • K111766Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic Biliary SystemsIdev Technologies, Inc. · 2011 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K010445Precise Nitinol Stent Transhepatic Billary SystemCordis Corp.2001—
−3K012993Modification to Precise Nitinol Stent Transhepatic Biliary SystemCordis Corp.20011
−2K021898Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp.20021
−1K031777Modeification to: Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp.20033
0 (this device)K032457Modification to Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp.2003—
+1K060557Suresave TM Self-Expandable Nitinol Stent and Precision TM Delivery…Idev Technologies, Inc.2006—
+2K071646Supera Interwoven Self-Expanding Biliary Nitinol Stent Delivery Catheter…Idev Technologies, Inc.2008—
+2K093893Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary…Idev Technologies, Inc.20101
+1K062798Smart Nitinol Self-Expanding Stent, Model C06120MB, C07120MB, C08120MB…Cordis Corp.20082
+2K111766Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic Biliary…Idev Technologies, Inc.20111

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
199910
200010
200110
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200610
200820
201010
201110
201220
201310
FIG. 1 — Lineage of K032457, 2001–2013Source: 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
*K021898Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp.20021
*K031777Modeification to: Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp.20033

Also cleared against K021898: 7 other devices →

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K060557Suresave TM Self-Expandable Nitinol Stent and Precision TM Delivery Catheter-SS06120060Idev Technologies, Inc.20066
K062798Smart Nitinol Self-Expanding Stent, Model C06120MB, C07120MB, C08120MB, C06150MB…Cordis Corp.20084
K042969Modification to Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp.20040

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 2 years and passes through 1 company; a new generation was cleared every 10 months on median.
  • 3 of the 9 ancestors have a recall of any class.
  • Of its descendants, K060557 (Idev Technologies, Inc., 2006) has gone furthest, with 6 descendants of its own.
  • 7 other devices also cite its predicate K021898.

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 S.M.A.R.T.TMControlTMNitinol Stent Transhepatic Biliary System is indicated for use in the palliation of malignant neoplasms in the biliary tree.

Indications for use as stated in the FDA summary.

Also cleared against K021898

7 other devices cite the same predicate.

  • K033393Absolute .035 Self-Expanding Biliary Stent SystemGuidant Corp. · 20035 recalls
  • K032137Precise RX Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 20031 recall
  • K031777Modeification to: Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 20033 recalls
  • K024303Edwards Lifesciences Lifestent NT18 Self-Expanding Biliary Stent and Delivery SystemEdwards Lifesciences, LLC · 2003
  • K031197Modification to Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 2003
  • K030409Smart Nitinol Stent Endoscopic Biliary SystemCordis Corp. · 2003

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/K032457 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032457: Modification to Smart Control Nitinol Stent Transhepatic Biliary System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032457

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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