# BXN: Stimulator, Nerve, Battery-Powered

- Device class: 2; regulation: 21 CFR 868.2775; FDA's rule: 510(k) required
- FDA decisions: 63
- 510(k) review time 2021–2025: median 389 days (middle half 389–389)
- 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)
- 2007: 3
- 2009: 2
- 2010: 1
- 2011: 2
- 2013: 1
- 2014: 1
- 2015: 1
- 2016: 1
- 2017: 1
- 2022: 1

## Most-cited predicates
- K052313: Stimuplex HNS-12, Model 4892098 (2005), cited by 4
- K102084: Stimpod NMS450 Nerve Stimulator (2010), cited by 4
- K913184: MS-Iii Ministim (1991), cited by 2
- K093591: Stimpod Model NMS-400 Nerve Stimulator (2009), cited by 2
- K072092: Xpod/Xmap Nerve Stimulator (2007), cited by 2
- K061172: Pajunk Multistim Sensor Nerve Stimulators (2006), cited by 1
- K121743: Easymed Peripheral Nerve Stimulator-Sunstin (2013), cited by 1
- K003983: Stimuplex HNS-11 (2001), cited by 1
- K883868: Model NS242 Constant Current Peripheral Nerve Stim (1988), cited by 1
- K062478: Clavis (2007), cited by 1

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