# QXM: Implanted Tibial Electrical Urinary Continence Device

- Device class: 2; regulation: 21 CFR 876.5305; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 126 days (middle half 122–130)
- Recalls: 0 (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)
- 2023: 1
- 2024: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K240037: Revi™ System (2024), cited by 2
- DEN220073: Revi System (2023), cited by 1

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