# IKT: Electrode, Needle, Diagnostic Electromyograph

- Device class: 2; regulation: 21 CFR 890.1385; FDA's rule: 510(k) required
- FDA decisions: 43
- 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)
- 2008: 1
- 2009: 3
- 2010: 2
- 2011: 2
- 2012: 1
- 2015: 1
- 2016: 1
- 2017: 1
- 2018: 1
- 2026: 1

## Most-cited predicates
- K973444: Teca Myoject Disposable Needle Electrodes (1997), cited by 6
- K990015: Electrode Needles (1999), cited by 5
- K931966: Dantec Disposable Concentric Needle (1994), cited by 5
- K973529: Neuroline, Disposable Concentric Needle Electrodes (1997), cited by 5
- K961013: Disposable Needle Electrode (1996), cited by 4
- K062437: Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and Private Labeled (2007), cited by 3
- K912282: Disposable Monopolar Needle Electrode, Var Models (1992), cited by 3
- K112034: Teca Elite Disposable Concentric Needles (2011), cited by 2
- K071186: Modification to: Ambu Neuroline Concentric Needle Electrode (2007), cited by 2
- K955335: Disposable Hypodermic Monopolar Needle Recording Electrode (1996), cited by 2

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