# JXE: Device, Nerve Conduction Velocity Measurement

- Device class: 2; regulation: 21 CFR 882.1550; FDA's rule: 510(k) required
- FDA decisions: 27
- 510(k) review time 2021–2025: median 427 days (middle half 427–427)
- 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)
- 1998: 1
- 2000: 2
- 2001: 2
- 2002: 1
- 2004: 1
- 2005: 1
- 2006: 2
- 2008: 1
- 2019: 1
- 2025: 1

## Most-cited predicates
- K982359: NC-Stat (1998), cited by 3
- K000565: Modification to NC-Stat (2000), cited by 3
- K013459: Modification of NC-Stat (2002), cited by 3
- K003508: NC-Stat (2001), cited by 3
- K060584: NC-Stat (2006), cited by 3
- K070109: Neurometrix Advance (2008), cited by 2
- K041320: Modification to NC-Stat (2004), cited by 2
- K843924: Digital Electroneurometer S-100 (1985), cited by 2
- K190536: Mediracer NCS (2019), cited by 1
- K963208: Nervepace (R) Nerve Conduction Viewscope (200VS) (1997), cited by 1

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