510(k) · Decided
DecidedBullseye Biliary Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Squareone · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Jul 29, 2009 as substantially equivalent to K010411 (Cordis Corp., 2001) and 1 other predicate after a 370-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it.
- Decided
- Jul 29, 2009
- Review
- 370 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K020682 (2002). 3 ancestors in all, the oldest K010411 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK020682 Bard Luminexx 6 FR Biliary Stent and Delivery SystemC.R. Bard, Inc. · 2002
- 1 generation backK033497 Bard Luminexx 3 Biliary Stent and Delivery SystemC.R. Bard, Inc. · 2004 · Recalled
- This deviceK082093 Bullseye Biliary Stent SystemSquareone · 2009
- Descendant · cites it directly · 0 of its ownK113582 Archstent Biliary SystemOstial Corporation · 2012
Most influential descendants
Showing 1 of 1 · See all- K113582Archstent Biliary SystemOstial Corporation · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K020682 | Bard Luminexx 6 FR Biliary Stent and Delivery System | C.R. Bard, Inc. | 2002 | — |
| −1 | K033497 | Bard Luminexx 3 Biliary Stent and Delivery System | C.R. Bard, Inc. | 2004 | 1 |
| 0 (this device) | K082093 | Bullseye Biliary Stent System | Squareone | 2009 | — |
| +1 | K113582 | Archstent Biliary System | Ostial Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (2)
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 |
|---|---|---|---|
| * | K010411 | Palmaz Genesis Transhepatic Billary Stent and Delivery SystemSummary page 1…nd comparisons demonstrate that the BullEye Biliary Stent System is substantially equivalent to the Cordis PALMAZ GENESIS Transhepatic Biliary Stent and Delivery System (K010411) and the Bard LUMINEXX 3 Biliary Stent and Delivery System (K033497) in terms of composition, design, intended use, and performan… | 2001 |
| * | K033497 | Bard Luminexx 3 Biliary Stent and Delivery SystemSummary page 1…substantially equivalent to the Cordis PALMAZ GENESIS Transhepatic Biliary Stent and Delivery System (K010411) and the Bard LUMINEXX 3 Biliary Stent and Delivery System (K033497) in terms of composition, design, intended use, and performance attributes. /~ ~ ~~~~ ~~ ~ ~ ~~~~… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113582 | Archstent Biliary System | 2012 | 0 |
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 7 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K113582 (Ostial Corporation, 2012) has gone furthest, with 0 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. 2009, 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?
BullsEye Biliary Stent System is indicated 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/K082093 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082093: Bullseye Biliary Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082093
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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