510(k) · Decided
Recalled · 2012Modeification to: Smart Control Nitinol Stent Transhepatic Biliary System
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 Jul 7, 2003 as substantially equivalent to K021898 (Cordis Corp., 2002) and 2 other predicates after a 27-day review. Its family tree reaches back 3 generations to 2001. 10 later devices descend from it. It has been recalled 3 times.
- Decided
- Jul 7, 2003
- Review
- 27 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 3 generations to K010445 (2001). 8 ancestors in all, the oldest K971010 (1997). 10 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK010445 Precise Nitinol Stent Transhepatic Billary SystemCordis Corp. · 2001
- 2 generations backK012993 Modification to Precise Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 2001 · Recalled
- 1 generation backK021898 Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 2002 · Recalled
- This deviceK031777 Modeification to: Smart Control Nitinol Stent Transhepatic Biliary…Cordis Corp. · 2003
- Descendant · cites it directly · 9 of its ownK032457 Modification to Smart Control Nitinol Stent Transhepatic Biliary…Cordis Corp. · 2003
- Descendant · 2 generations on · 6 of its ownK060557 Suresave TM Self-Expandable Nitinol Stent and Precision TM Delivery…Idev Technologies, Inc. · 2006
- Descendant · 3 generations on · 5 of its ownK071646 Supera Interwoven Self-Expanding Biliary Nitinol Stent Delivery…Idev Technologies, Inc. · 2008
- Descendant · 3 generations on · 4 of its ownK093893 Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic…Idev Technologies, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 4 of its ownK062798 Smart Nitinol Self-Expanding Stent, Model C06120MB, C07120MB…Cordis Corp. · 2008 · Recalled
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- 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
- K062798Smart Nitinol Self-Expanding Stent, Model C06120MB, C07120MB, C08120MB, C06150MB…Cordis Corp. · 2008 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010445 | Precise Nitinol Stent Transhepatic Billary System | Cordis Corp. | 2001 | — |
| −2 | K012993 | Modification to Precise Nitinol Stent Transhepatic Biliary System | Cordis Corp. | 2001 | 1 |
| −1 | K021898 | Smart Control Nitinol Stent Transhepatic Biliary System | Cordis Corp. | 2002 | 1 |
| 0 (this device) | K031777 | Modeification to: Smart Control Nitinol Stent Transhepatic Biliary System | Cordis Corp. | 2003 | — |
| +1 | K032457 | Modification to Smart Control Nitinol Stent Transhepatic Biliary System | Cordis Corp. | 2003 | — |
| +2 | K060557 | Suresave TM Self-Expandable Nitinol Stent and Precision TM Delivery… | Idev Technologies, Inc. | 2006 | — |
| +3 | K071646 | Supera Interwoven Self-Expanding Biliary Nitinol Stent Delivery Catheter… | Idev Technologies, Inc. | 2008 | — |
| +3 | K093893 | Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary… | Idev Technologies, Inc. | 2010 | 1 |
| +2 | K062798 | Smart Nitinol Self-Expanding Stent, Model C06120MB, C07120MB, C08120MB… | Cordis Corp. | 2008 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K021898 | Smart Control Nitinol Stent Transhepatic Biliary System | 2002 |
| * | K994068 | S.M.a.R.T. Nitinol Stent Transhepatic Biliary SystemSummary page 1…1O(k) ## KO2 1898 - August 14,2002) - Cordis Corporation. S.M.A.R.T.TMNitinol Stent Transhepatic Biliary System (5 10(k) # K994068 - December 23, 1999 - Cordis Corporation. Bard LUMINEXXTM6 Fr Biliary Stent and Delivery System (510(k) #… | 1999 |
| * | K020682 | Bard Luminexx 6 FR Biliary Stent and Delivery System | 2002 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032457 | Modification to Smart Control Nitinol Stent Transhepatic Biliary System | 2003 | 9 |
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… |
| Jan 31, 2012 | Not classified | Z-1039-2012 | Packaging | Cordis Corporation initiated a recall of S.M.A.R.T. CONTROL Transhepatic Biliary Stent due to a potential sterility breach in the pouches. |
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.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K032457 (Cordis Corp., 2003) has gone furthest, with 9 descendants of its own.
- 7 other devices also cite its predicate K021898.
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.
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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K031777 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031777: Modeification 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/K031777
Report an extraction error
Are you the manufacturer?
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