# BXM: Stimulator, Nerve, Ac-Powered

- Device class: 2; regulation: 21 CFR 868.2775; FDA's rule: 510(k) required
- FDA decisions: 4
- 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)
- 1987: 1
- 1993: 1
- 2000: 1
- 2001: 1

## Most-cited predicates
- K002677: Nuvasive Ins-1 Intraoperative Nerve Surveillance System (2000), cited by 5
- K013215: Modified Ins-1 Intraoperative Nerve Surveillance System (2001), cited by 1
- K921498: Ver Med A10011 PNS Dual Element Electrode (1993), cited by 1

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