510(k) · Cleared
ClearedOasis Biliary Stent Introduction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Feb 20, 2004 as substantially equivalent to K851962 (Wilson-Cook Medical, Inc., 1985) after a 28-day review. Its family tree reaches back 1 generation to 1985. 5 later devices descend from it.
- Decided
- Feb 20, 2004
- Review
- 28 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K851962 (1985). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK851962 Zimmon Biliary Stent SetWilson-Cook Medical, Inc. · 1985 · Recalled
- This deviceK040151 Oasis Biliary Stent Introduction SystemWilson-Cook Medical, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK172044 Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung…Cook Ireland, Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK251658 Endoflux™ Biliary & Pancreatic Stent SetsMedi-Globe GmbH · 2026
- Descendant · 2 generations on · 0 of its ownK230127 Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary…Micro-Tech (Nanjing) Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK213946 Compass BDS Biliary StentCook Ireland, Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK060624 Marathon Stent with Fusion TechnologyCook Ireland, Ltd. · 2006
Most influential descendants
Showing 5 of 5 · See all- K172044Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary…Cook Ireland, Ltd. · 2018 · cites it directly3descendants
- K251658Endoflux™ Biliary & Pancreatic Stent SetsMedi-Globe GmbH · 2026 · 2 generations on0descendants
- K230127Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set…Micro-Tech (Nanjing) Co., Ltd. · 2023 · 2 generations on0descendants
- K213946Compass BDS Biliary StentCook Ireland, Ltd. · 2022 · 2 generations on0descendants
- K060624Marathon Stent with Fusion TechnologyCook Ireland, Ltd. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K851962 | Zimmon Biliary Stent Set | Wilson-Cook Medical, Inc. | 1985 | 5 |
| 0 (this device) | K040151 | Oasis Biliary Stent Introduction System | Wilson-Cook Medical, Inc. | 2004 | — |
| +1 | K172044 | Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex… | Cook Ireland, Ltd. | 2018 | — |
| +2 | K251658 | Endoflux™ Biliary & Pancreatic Stent Sets | Medi-Globe GmbH | 2026 | — |
| +2 | K230127 | Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent… | Micro-Tech (Nanjing) Co., Ltd. | 2023 | — |
| +2 | K213946 | Compass BDS Biliary Stent | Cook Ireland, Ltd. | 2022 | — |
| +1 | K060624 | Marathon Stent with Fusion Technology | Cook Ireland, Ltd. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K851962 | Zimmon Biliary Stent SetSummary page 1…21 CFR § 876.5010 78 FGE PREDICATE DEVICES: Zimmon Endoscopic Biliary Stent Sets (k851 962/A) Wilson-Cook's OASIS Biliary Stent Introducer INTENDED USE:… | 1985 |
| * | — | Wilson-Cook's OASIS Biliary Stent Introducer System Named without a submission number |
What descends from it? (5)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 OASIS Biliary Stent Introduction System is intended for endoscopic biliary stent placement
to drain obstructed bile ducts.
The device is supplied sterile and intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040151 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040151: Oasis Biliary Stent Introduction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040151
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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