# KOI: Stimulator, Nerve, Peripheral, Electric

- Device class: 2; regulation: 21 CFR 868.2775; FDA's rule: 510(k) required
- FDA decisions: 29
- 510(k) review time 2021–2025: median 192 days (middle half 106–249)
- 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)
- 2005: 1
- 2016: 1
- 2018: 2
- 2019: 1
- 2020: 1
- 2021: 2
- 2022: 3
- 2024: 1
- 2025: 2
- 2026: 1

## Most-cited predicates
- K023342: Neuro-Trace Iii Kit, Neuro-Trace Iii Regional Block Cable, Neuro-Trace Iii Nerve Mapping Probe, Neuro-Trace Iii Nerve BG (2004), cited by 4
- K172690: ToFscan (2018), cited by 3
- K190795: Tetragraph Neuromuscular Transmission Monitor (2019), cited by 2
- K992598: Tof-Watch SX (1999), cited by 2
- K972698: Tof-Watch (1997), cited by 2
- K201949: Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series (2021), cited by 2
- K954505: EZ Stim (1996), cited by 2
- K955026: AS/3 NMT Module (1997), cited by 2
- K051635: Datex-Ohmeda S/5 Neuromuscular Transmission Module, E-NMT and Accessories (2005), cited by 1
- K212434: Neuromuscular Transmission Monitor TOF3D (2022), cited by 1

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