# IKN: Electromyograph, Diagnostic

- Device class: 2; regulation: 21 CFR 890.1375; FDA's rule: 510(k) required
- FDA decisions: 75
- 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)
- 2005: 1
- 2007: 1
- 2008: 1
- 2009: 1
- 2011: 2
- 2012: 1
- 2013: 2
- 2014: 1
- 2015: 1
- 2017: 3

## Most-cited predicates
- K890495: Nicolet Viking II System (1989), cited by 5
- K802637: Teca Model-10 Electromyograph (1980), cited by 4
- K073415: Nemus System; Nemus PC Peripheral (2008), cited by 4
- K102610: Focus Emg Device (2011), cited by 3
- K023209: Insight Millennium Iii (2003), cited by 3
- K162383: Cadwell Sierra Summit, Cadwell Sierra Ascent (2017), cited by 2
- K022719: Physical Monitoring Registration Unit (2002), cited by 2
- K922488: Phasis Electromyograph (1993), cited by 2
- K842956: Nicolet Viking (1984), cited by 2
- K002104: Combined Physiological Monitoring System (2000), cited by 2

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