510(k) · Cleared
ClearedEndoflux™ Biliary & Pancreatic Stent Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medi-Globe GmbH · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Apr 16, 2026 as substantially equivalent to K172044 (Cook Ireland, Ltd., 2018) and 1 other predicate after a 321-day review. Its family tree reaches back 3 generations to 1985.
- Decided
- Apr 16, 2026
- Review
- 321 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K851962 (1985). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK851962 Zimmon Biliary Stent SetWilson-Cook Medical, Inc. · 1985 · Recalled
- 2 generations backK040151 Oasis Biliary Stent Introduction SystemWilson-Cook Medical, Inc. · 2004
- 1 generation backK172044 Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung…Cook Ireland, Ltd. · 2018
- This deviceK251658 Endoflux™ Biliary & Pancreatic Stent SetsMedi-Globe GmbH · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K851962 | Zimmon Biliary Stent Set | Wilson-Cook Medical, Inc. | 1985 | 5 |
| −2 | 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 | — |
| 0 (this device) | K251658 | Endoflux™ Biliary & Pancreatic Stent Sets | Medi-Globe GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1999 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K172044 | Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary…Summary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K172044 Cotton-Huibregtse® Biliary Stent, Cotton-Leung® Biliary Stent, FGE Cotton- Leung®… | 2018 |
| * | K172057 | Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing…Summary page 5…ton-Leung® Biliary Stent, Oasis® One Action Stent Introduction System with preloaded ST-2 Tannenbaum® Biliary Stent. K172057 Zimmon® Pancreatic Stent/Stent sets, Geenen® Pancreatic FGE Stents/Stent S… | 2018 |
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 41 years and passes through 3 companies; a new generation was cleared every 14.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 2 other devices also cite its predicate K172044.
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. 2026, 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?
Biliary Stents/Stent sets are used to drain obstructed biliary ducts Pancreatic Stents/Stent sets are used to drain obstructed pancreatic ducts Guiding Catheters, Pushers, and Stent Introducer Sets are used for endoscopic biliary and pancreatic stent placement
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K251658 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251658: Endoflux™ Biliary & Pancreatic Stent Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251658
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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