510(k) · Decided
Recalled · 2012Smart Nitinol Self-Expanding Stent, Model C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Corp. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Feb 6, 2008 as substantially equivalent to K032457 (Cordis Corp., 2003) and 3 other predicates after a 505-day review. Its family tree reaches back 5 generations to 2001. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 6, 2008
- Review
- 505 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 5 generations to K010445 (2001). 12 ancestors in all, the oldest K971010 (1997). 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK010445 Precise Nitinol Stent Transhepatic Billary SystemCordis Corp. · 2001
- 4 generations backK012993 Modification to Precise Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 2001 · Recalled
- 3 generations backK021898 Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 2002 · Recalled
- 2 generations backK031777 Modeification to: Smart Control Nitinol Stent Transhepatic Biliary…Cordis Corp. · 2003 · Recalled
- 1 generation backK032457 Modification to Smart Control Nitinol Stent Transhepatic Biliary…Cordis Corp. · 2003
- This deviceK062798 Smart Nitinol Self-Expanding Stent, Model C06120MB, C07120MB…Cordis Corp. · 2008
- Descendant · cites it directly · 2 of its ownK111766 Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic…Idev Technologies, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 1 of its ownK122546 Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic…Idev Technologies, Inc. · 2012
- Descendant · 3 generations on · 0 of its ownK130591 Supera VeritasIdev Technologies, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK111627 Supera Veritas (R) Interwoven Self-Expanding Nitinol Stent…Idev Technologies, Inc. · 2012
Most influential descendants
Showing 4 of 4 · See all- K111766Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic Biliary SystemsIdev Technologies, Inc. · 2011 · cites it directly2descendants
- K122546Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemIdev Technologies, Inc. · 2012 · 2 generations on1descendant
- K130591Supera VeritasIdev Technologies, Inc. · 2013 · 3 generations on0descendants
- K111627Supera Veritas (R) Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemIdev Technologies, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010445 | Precise Nitinol Stent Transhepatic Billary System | Cordis Corp. | 2001 | — |
| −4 | K012993 | Modification to Precise Nitinol Stent Transhepatic Biliary System | Cordis Corp. | 2001 | 1 |
| −3 | K021898 | Smart Control Nitinol Stent Transhepatic Biliary System | Cordis Corp. | 2002 | 1 |
| −2 | K031777 | Modeification to: Smart Control Nitinol Stent Transhepatic Biliary System | Cordis Corp. | 2003 | 3 |
| −1 | K032457 | Modification to Smart Control Nitinol Stent Transhepatic Biliary System | Cordis Corp. | 2003 | — |
| 0 (this device) | K062798 | Smart Nitinol Self-Expanding Stent, Model C06120MB, C07120MB, C08120MB… | Cordis Corp. | 2008 | — |
| +1 | K111766 | Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic Biliary… | Idev Technologies, Inc. | 2011 | 1 |
| +2 | K122546 | Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary… | Idev Technologies, Inc. | 2012 | — |
| +3 | K130591 | Supera Veritas | Idev Technologies, Inc. | 2013 | — |
| +1 | K111627 | Supera Veritas (R) Interwoven Self-Expanding Nitinol Stent Transhepatic… | Idev Technologies, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
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 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032457 | Modification to Smart Control Nitinol Stent Transhepatic Biliary SystemSummary page 1…is substantially equivalent to: Predicate * Cordis S.M.A.R.TA9 CONTROLTm Nitinol Stent Transhepatic Biliary Devices System (510O(k) # K03245 7) * Cordis S.M.A.R.T.0 Nitinol Stent Transhepatic Biliary System (510(k) # K… | 2003 |
| * | K003336 | Modification to S.M.a.R.T Nitinol Stent Transhepatic Biliary SystemSummary page 1…System (510O(k) # K03245 7) * Cordis S.M.A.R.T.0 Nitinol Stent Transhepatic Biliary System (510(k) # K003336) * Cordis PRECISETm Nitinol Stent Transhepatic Biliary System (510O(k) #K01… | 2000 |
| * | K010445 | Precise Nitinol Stent Transhepatic Billary SystemSummary page 1…(510(k) # K003336) * Cordis PRECISETm Nitinol Stent Transhepatic Biliary System (510O(k) #K010445) * ev3 Prot~g6 EverFlex Self-Expanding Nitinol Stent (510(k)#K060057) Classification Class IL.… | 2001 |
| * | K060057 | Protege Everflex Self-Expanding Biliary Stent SystemSummary page 1…ol Stent Transhepatic Biliary System (510O(k) #K010445) * ev3 Prot~g6 EverFlex Self-Expanding Nitinol Stent (510(k)#K060057) Classification Class IL. Performance Performance standards have not been established by the FDA under secti… | 2006 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 9, 2012 | Not classified | Z-1508-2012 | Packaging process control | Cordis Corporation is recalling 32 lots of Cordis S.M.A.R.T. Nitinol Stent Transhepatic Biliary System and S.M.A.R.T. Control Nitinol Stent Transhepatic Biliary System. There is a potential for a sterility breach due to holes or tears in… |
| Apr 9, 2012 | Not classified | Z-1507-2012 | Packaging process control | Cordis Corporation is recalling 32 lots of Cordis S.M.A.R.T. Nitinol Stent Transhepatic Biliary System and S.M.A.R.T. Control Nitinol Stent Transhepatic Biliary System. There is a potential for a sterility breach due to holes or tears in… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 10 months on median.
- 4 of the 12 ancestors have a recall of any class.
- Of its descendants, K111766 (Idev Technologies, Inc., 2011) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K032457.
How does its category compare?
All FGE devicesFGE Stents, Drains And Dilators For The Biliary Ducts: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · FGE
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGE
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGE
1,923in 2025
MAUDE reports naming product code FGE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 316 | 54 | 1,006 |
| 2008 | 11 | 214 | 93 | 1,465 |
| 2009 | 7 | 160 | 18 | 1,655 |
| 2010 | 9 | 81 | 32 | 1,434 |
| 2011 | 9 | 114 | 2 | 1,321 |
| 2012 | 8 | 96 | 4 | 1,183 |
| 2013 | 5 | 161 | 3 | 1,060 |
| 2014 | 8 | 156 | 0 | 1,270 |
| 2015 | 8 | 79 | 0 | 1,543 |
| 2016 | 4 | 49 | 0 | 1,453 |
| 2017 | 9 | 59 | 1 | 1,515 |
| 2018 | 7 | 215 | 43 | 1,681 |
| 2019 | 2 | — | 13 | 1,896 |
| 2020 | 4 | 121 | 1 | 2,182 |
| 2021 | 1 | — | 27 | 2,297 |
| 2022 | 6 | 101 | 21 | 1,749 |
| 2023 | 6 | 199 | 19 | 1,615 |
| 2024 | 6 | 188 | 1 | 1,948 |
| 2025 | 7 | 257 | 0 | 1,923 |
| 2026 | 8 | 153 | 11 | — |
What is it indicated for?
The S.M.A.R.T.® Nitinol Stent Transhepatic Biliary System is intended for palliation of malignant
strictures in the biliary tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062798 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062798: Smart Nitinol Self-Expanding Stent, Model C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062798
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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