# ETN: Stimulator, Nerve

- Device class: 2; regulation: 21 CFR 874.1820; FDA's rule: 510(k) required
- FDA decisions: 97
- 510(k) review time 2021–2025: median 172 days (middle half 93–264)
- Recalls: 9 (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)
- 2014: 2
- 2015: 1
- 2016: 2
- 2020: 1
- 2021: 1
- 2022: 2
- 2023: 5
- 2024: 2
- 2025: 1
- 2026: 2

## Most-cited predicates
- K031003: Stimulus/Dissection Instruments, Ball-Tip Probes (2003), cited by 9
- K992869: Xomed Ball-Tip Monopolar Stimulator Probe (1999), cited by 7
- K925640: Xomed-Treace Emg Endotracheal Tubeen (1993), cited by 5
- K103128: Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw Stimulator Probe, (2011), cited by 5
- K014165: Stimulus - Dissection Instruments (2002), cited by 4
- K980148: Neurosign 800, 8 Channel Motor Nerve Monitor (1998), cited by 4
- K112718: Nuvasive NVM5 System (2012), cited by 4
- K003745: Laryngeal Surface Electrode-Endotracheal Tube, M-500-ET, Lse-ET (2001), cited by 4
- K031510: Nim-Spine (2003), cited by 4
- K110989: Neurovision Ink Printed Endotracheal Tube Electrode (2011), cited by 3

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