# K935094: Balloon Dilation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Jan 24, 1995 after 459 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K061937: Cook Endoscopy Esophageal Dilation Balloon (2006), 1 descendant of its own
- K171223: Quantum TTC Biliary Balloon Dilator (2017), 0 descendants of its own
- K090183: Hercules 3 Stage Wire Guided Dilation Balloon (2009), 0 descendants of its own
- K080158: LB Medical Inflatable Tissue Elevator/Expander System (2008), 0 descendants of its own
- K040800: Wilosn-Cook Biliary Dilation Balloon (2004), 0 descendants of its own

## Recalls of this device
- Jan 24, 2007 · Not classified · Z-0520-2007: The graphic label is incorrect, it lists 6mm/ 18FR. The product label is correct, it lists 10mm/ 30FR.
- Sep 15, 2003 · Not classified · Z-1292-03: The product was labeled 'esophageal', but contained a 'biliary' ballon

Source page: https://510kreport.com/device/K935094
Methodology: https://510kreport.com/methodology