# K925406: Biliary Endoprostheses W/Unistep Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Schneider Intl., Ltd.
- Decided: Jan 11, 1995 after 807 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
35 later devices descend from it; 3 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K962899: Ultraflex Diamond (1997), 22 descendants of its own
- K012883: Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System, Ultraflex Tracheobronchial Stent System (2001), 21 descendants of its own
- K073266: Wallflex Partially Covered Esophageal Stent System (2008), 15 descendants of its own
- K091510: Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720, M00516730 (2009), 14 descendants of its own
- K061231: Wellflex  Biliary RX Stent System (2006), 10 descendants of its own

Source page: https://510kreport.com/device/K925406
Methodology: https://510kreport.com/methodology