510(k) Report

510(k) · Decided

Recalled · 2003

Smart Control Nitinol Stent Transhepatic Biliary System

K021898510(k) SpecialDecided Aug 14, 200265-day reviewClass II21 CFR 876.5010Recalls 1

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 Aug 14, 2002 as substantially equivalent to K012993 (Cordis Corp., 2001) and 3 other predicates after a 65-day review. Its family tree reaches back 2 generations to 2001. 24 later devices descend from it. It has been recalled once.

Decided
Aug 14, 2002
Review
65 days
Class
Class II
Product code
FGE
Recalls
1
Predicates
4

Its longest line of descent runs back 2 generations to K010445 (2001). 5 ancestors in all, the oldest K971010 (1997). 24 later devices descend from it, 8 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2000: 1 other ancestor1997: 1 other ancestor2003: 7 descendants cleared2002: 1 descendant cleared2004: 2 descendants cleared2005: 1 descendant cleared2006: 2 descendants cleared2008: 4 descendants cleared2013: 2 descendants cleared2010: 2 descendants cleared2012: 2 descendants cleared2011: 1 descendant clearedK010445 · Precise Nitinol Stent Transhepatic Billary System · Cordis Corp. · 2001K012993 · Modification to Precise Nitinol Stent Transhepatic Biliary System · Cordis Corp. · 2001 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 8 descendants2 generations forward: 7 descendants3 generations forward: 7 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K012993 · Modification to Precise Nitinol Stent Transhepatic Biliary System · Cordis Corp. · 2001 · recalledK010445 · Precise Nitinol Stent Transhepatic Billary System · Cordis Corp. · 20010+5
  1. Root · 2 generations backK010445 Precise Nitinol Stent Transhepatic Billary SystemCordis Corp. · 2001
  2. 1 generation backK012993 Modification to Precise Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 2001 · Recalled
  3. This deviceK021898 Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 2002
  4. Descendant · cites it directly · 10 of its ownK031777 Modeification to: Smart Control Nitinol Stent Transhepatic Biliary…Cordis Corp. · 2003 · Recalled
  5. Descendant · cites it directly · 9 of its ownK032457 Modification to Smart Control Nitinol Stent Transhepatic Biliary…Cordis Corp. · 2003
  6. Descendant · 2 generations on · 6 of its ownK060557 Suresave TM Self-Expandable Nitinol Stent and Precision TM Delivery…Idev Technologies, Inc. · 2006
  7. Descendant · 3 generations on · 5 of its ownK071646 Supera Interwoven Self-Expanding Biliary Nitinol Stent Delivery…Idev Technologies, Inc. · 2008
  8. Descendant · 3 generations on · 4 of its ownK093893 Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic…Idev Technologies, Inc. · 2010 · Recalled

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2002: 12003: 72004: 22005: 12006: 22008: 42010: 22011: 12012: 22013: 2
2002high 7 (2003) · low 0 (2007)2026

Most influential descendants

Showing 5 of 24 · See all
  • K031777Modeification to: Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 2003 · cites it directly10descendants
  • K032457Modification to Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 2003 · cites it directly9descendants
  • K060557Suresave TM Self-Expandable Nitinol Stent and Precision TM Delivery Catheter-SS06120060Idev Technologies, Inc. · 2006 · 2 generations on6descendants
  • K071646Supera Interwoven Self-Expanding Biliary Nitinol Stent Delivery Catheter, Model #…Idev Technologies, Inc. · 2008 · 3 generations on5descendants
  • K093893Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemIdev Technologies, Inc. · 2010 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K010445Precise Nitinol Stent Transhepatic Billary SystemCordis Corp.2001—
−1K012993Modification to Precise Nitinol Stent Transhepatic Biliary SystemCordis Corp.20011
0 (this device)K021898Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp.2002—
+1K031777Modeification to: Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp.20033
+1K032457Modification to Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp.2003—
+2K060557Suresave TM Self-Expandable Nitinol Stent and Precision TM Delivery…Idev Technologies, Inc.2006—
+3K071646Supera Interwoven Self-Expanding Biliary Nitinol Stent Delivery Catheter…Idev Technologies, Inc.2008—
+3K093893Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary…Idev Technologies, Inc.20101

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200010
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200370
200420
200510
200620
200840
201020
201110
201220
201320
FIG. 1 — Lineage of K021898, 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? (4)

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
*K012993Modification to Precise Nitinol Stent Transhepatic Biliary SystemCordis Corp.20011
*K001843S.M.a.R.T. Nitinol Stent Transhepatic Biliary SystemCordis Corp.2000—
*K971010Peripheral Transluminal Angioplasty Catheters
Summary page 1
…(Improved Radiopacity) (5 1O(k) # KO01843 - July 18,2000 - Cordis Corporation. Cordis SAVVYTM PTA Balloon Catheter (5 1O(k) # K97 1010 - June 18, 1997) - Cordis Corporation. Bridge SE Self Expanding Stent Delivery System…
Cordis Corp.1997—
*K011080Bridge SE Self-Expanding Stent Delivery SystemMedtronic Ave, Inc.2001—

Also cleared against K012993: 2 other devices →

What descends from it? (24)

See all 24

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

NumberDeviceApplicantDecidedDescendants
K031777Modeification to: Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp.200310
K032457Modification to Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp.20039
K024303Edwards Lifesciences Lifestent NT18 Self-Expanding Biliary Stent and Delivery SystemEdwards Lifesciences, LLC20034
K033393Absolute .035 Self-Expanding Biliary Stent SystemGuidant Corp.20033
K023217Modification to Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp.20022
K032137Precise RX Nitinol Stent Transhepatic Biliary SystemCordis Corp.20030
K031197Modification to Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp.20030
K030409Smart Nitinol Stent Endoscopic Biliary SystemCordis Corp.20030

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 3, 2003Not classifiedZ-0707-03OtherThe SMART Control Stent Delivery System may not fully deploy or be difficult to deploy under certain circumstances.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 1 year and passes through 1 company; a new generation was cleared every 10 months on median.
  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K031777 (Cordis Corp., 2003) has gone furthest, with 10 descendants of its own.
  • 2 other devices also cite its predicate K012993.

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 SMART Control Nitinol 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 K012993

2 other devices cite the same predicate.

  • K032137Precise RX Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 20031 recall
  • K024303Edwards Lifesciences Lifestent NT18 Self-Expanding Biliary Stent and Delivery SystemEdwards Lifesciences, LLC · 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/K021898 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021898: 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/K021898

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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