# JXI: Cuff, Nerve

- Device class: 2; regulation: 21 CFR 882.5275; FDA's rule: 510(k) required
- FDA decisions: 40
- 510(k) review time 2021–2025: median 123 days (middle half 104–278)
- 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)
- 2016: 3
- 2017: 3
- 2018: 1
- 2019: 1
- 2020: 1
- 2022: 2
- 2023: 3
- 2024: 3
- 2025: 4
- 2026: 2

## Most-cited predicates
- K011168: Neurogen Nerve Guide (2001), cited by 9
- K041620: Neura Wrap Nerve Protector (2004), cited by 6
- K002098: Salumedica Nerve Cuff (2000), cited by 5
- K060952: Collagen Nerve Wrap (2006), cited by 4
- K012814: Collagen Nerve Cuff (2001), cited by 4
- K031069: Surgisis Nerve Cuff (2003), cited by 3
- K103081: Covaortho-Nerve Resorbable Collagen Membrane (2012), cited by 3
- K112267: Neurolac (R) Nerve Guide (2011), cited by 3
- K132660: Nerve Cuff (2014), cited by 3
- K232029: VersaWrap Nerve Protector (2023), cited by 2

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