# K011031: Vysis Urovysion Bladder Cancer Recurrence Kit

- Pathway: 510(k) (Traditional)
- Applicant: Vysis
- Decided: Aug 3, 2001 after 120 days
- Product code: MMW (System, Test, Tumor Marker, Monitoring, Bladder)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 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
- K050840: Modification to Duet System (2005), 7 descendants of its own
- K061602: Duet System (2007), 5 descendants of its own
- K101291: Scanview HER2/Neu Fish System (2010), 2 descendants of its own
- K110345: Scanview System (2011), 1 descendant of its own
- K130775: Duet System (2014), 0 descendants of its own

## Recalls of this device
- Feb 19, 2004 · Not classified · Z-0640-04: Some of the control slides did not have adequate cells deposited upon their surface.

Source page: https://510kreport.com/device/K011031
Methodology: https://510kreport.com/methodology