# MBX: Stimulator, Thalamic, Epilepsy, Implanted

- Device class: 3; regulation: 21 CFR —; FDA's rule: Pathway set case by case
- FDA decisions: 0
- 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)
- 2018: 1
- 2022: 1
- 2023: 1
- 2024: 1

## Most-cited predicates

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