510(k) · Cleared
Recalled · 2008Zimmon Biliary Stent Set
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 Dec 17, 1985 after a 228-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it. It has been recalled 5 times.
- Decided
- Dec 17, 1985
- Review
- 228 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 5
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK851962 Zimmon Biliary Stent SetWilson-Cook Medical, Inc. · 1985
- Descendant · cites it directly · 5 of its ownK040151 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
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K040151Oasis Biliary Stent Introduction SystemWilson-Cook Medical, Inc. · 2004 · cites it directly5descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K851962 | Zimmon Biliary Stent Set | Wilson-Cook Medical, Inc. | 1985 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 2, 2008 | Not classified | Z-2332-2008 | Process control | It is possible the stents inside CLSO-10-10, lot W2512492 were 5cm in length, instead of 10cm in length as listed on the product packaging label. |
| Jul 2, 2008 | Not classified | Z-2331-2008 | Process control | The product packaging label indicates the stent is 5cm, but the actual stent inside the packaging measures 10cm. |
| Jun 9, 2005 | Not classified | Z-0940-05 | Other | The reorder number listed on the product label is inaccurate. |
| Apr 21, 2004 | Not classified | Z-0908-04 | Other | The guiding catheter provided with the SIS-10 biliary stent introduction system may be a 5 French instead of the required 6 French guiding catheter. |
| Dec 22, 2003 | Not classified | Z-0347-04 | Other | Mislabeling; Incorrect statement, Minimum Accessory Channel Size: 3.7mm, should state, Minimum Accessory Channel Size 4.2mm |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K040151 (Wilson-Cook Medical, Inc., 2004) has gone furthest, with 5 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 | — |
https://510kreport.com/device/K851962 · printed Nov 6, 2026
Cite this page
510(k) Report. “K851962: Zimmon Biliary Stent Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K851962
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026