510(k) · Decided
DecidedArchstent Biliary System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ostial Corporation · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Jun 29, 2012 as substantially equivalent to K082093 (Squareone, 2009) after a 207-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Jun 29, 2012
- Review
- 207 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K020682 (2002). 4 ancestors in all, the oldest K010411 (2001). No later device cites it as a predicate yet.
- Root · 3 generations backK020682 Bard Luminexx 6 FR Biliary Stent and Delivery SystemC.R. Bard, Inc. · 2002
- 2 generations backK033497 Bard Luminexx 3 Biliary Stent and Delivery SystemC.R. Bard, Inc. · 2004 · Recalled
- 1 generation backK082093 Bullseye Biliary Stent SystemSquareone · 2009
- This deviceK113582 Archstent Biliary SystemOstial Corporation · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K020682 | Bard Luminexx 6 FR Biliary Stent and Delivery System | C.R. Bard, Inc. | 2002 | — |
| −2 | K033497 | Bard Luminexx 3 Biliary Stent and Delivery System | C.R. Bard, Inc. | 2004 | 1 |
| −1 | K082093 | Bullseye Biliary Stent System | Squareone | 2009 | — |
| 0 (this device) | K113582 | Archstent Biliary System | Ostial Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (1)
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 |
|---|---|---|---|
| * | K082093 | Bullseye Biliary Stent SystemSummary page 1…ormance and Intended Use: The ArchStent Biliary System is a modified version of the BullsEye Biliary Stent System, which was cleared via 5 10(k) #K082093 on July 29, 2009. Minor design changes were implemented to improve usability and offer additional stent diameters and cat… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 10 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 4 ancestors have a recall of any class.
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. 2012, 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 ArchStent Biliary system is intended for use in the palliation of
malignant neoplasms in the biliary tree
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113582 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113582: Archstent Biliary System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113582
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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