510(k) · Decided
Recalled · 2004Sentinol Nitinol Billary Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Sep 25, 2003 after an 87-day review. The FDA summary names its predicate without a number. 3 later devices descend from it. It has been recalled once.
- Decided
- Sep 25, 2003
- Review
- 87 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK032025 Sentinol Nitinol Billary Stent SystemBoston Scientific Corp · 2003
- Descendant · cites it directly · 2 of its ownK072301 5MM Protege Everflex Self Expanding Biliary Stent System, Model…Ev3, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK262913 Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemMedtronic, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK111627 Supera Veritas (R) Interwoven Self-Expanding Nitinol Stent…Idev Technologies, Inc. · 2012
Most influential descendants
Showing 3 of 3 · See all- K0723015MM Protege Everflex Self Expanding Biliary Stent System, Model PRP35-05Ev3, Inc. · 2008 · cites it directly2descendants
- K262913Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemMedtronic, Inc. · 2026 · 2 generations on0descendants
- K111627Supera Veritas (R) Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemIdev Technologies, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032025 | Sentinol Nitinol Billary Stent System | Boston Scientific Corp | 2003 | — |
| +1 | K072301 | 5MM Protege Everflex Self Expanding Biliary Stent System, Model PRP35-05 | Ev3, Inc. | 2008 | — |
| +2 | K262913 | Protégé™ EverFlex™ Self-expanding Peripheral Stent System | Medtronic, Inc. | 2026 | — |
| +2 | K111627 | Supera Veritas (R) Interwoven Self-Expanding Nitinol Stent Transhepatic… | Idev Technologies, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | — | Boston Scientific Wallstent Biliary Endoprosthesis with Unistep Plus RP Delivery System Named without a submission number | |
| * | — | Cordis S.M.A.R.T.TM Nitinol Stent Transhepatic Biliary System Named without a submission number | |
| * | — | Guidant DYNALINKTM Biliary Self-Expanding Stent System Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072301 | 5MM Protege Everflex Self Expanding Biliary Stent System, Model PRP35-05 | 2008 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 14, 2004 | Not classified | Z-0440-06 | Other | One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. The product, pouch label and carton label are all correct and the correct DFU is in the package. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K072301 (Ev3, Inc., 2008) has gone furthest, with 2 descendants of its own.
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 Boston Boston Scientific SentinolTMNitinol Biliary Stent System is indicated for palliation of malignant neoplasms in the biliary tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032025 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032025: Sentinol Nitinol Billary Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032025
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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