# MMW: System, Test, Tumor Marker, Monitoring, Bladder

- Device class: 2; regulation: 21 CFR 866.6010; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 912 days (middle half 912–912)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1997: 2
- 1998: 2
- 2001: 1
- 2002: 2
- 2004: 1
- 2023: 1

## Most-cited predicates
- K964151: Bard and Bta Test (1997), cited by 3
- K013785: Urovysion Bladder Cancer Recurrence Kit (2002), cited by 1
- K970353: Aura Tek FDP (1997), cited by 1
- K011031: Vysis Urovysion Bladder Cancer Recurrence Kit (2001), cited by 1
- K033982: Modification to Vysis Urovysion Bladder Cancer Recurrence Test (2004), cited by 1

Source page: https://510kreport.com/product-code/MMW
Data by year (CSV): https://510kreport.com/product-code/MMW.csv