# K001869: Diagnostic Electromyography Needle Electrode, Disposable Hypodermic Needle

- Pathway: 510(k) (Traditional)
- Applicant: Medicotest A/S
- Decided: Sep 18, 2000 after 90 days
- Product code: IKT (Electrode, Needle, Diagnostic Electromyograph)
- Device class: 2
- Regulation: 21 CFR 890.1385
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K091410: Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot, (2009), 2 descendants of its own
- K092973: Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar Needle (2010), 1 descendant of its own
- K152984: Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes (2016), 0 descendants of its own
- K093825: Ambu Neuroline Disposable Inoject Needle Electrode (2010), 0 descendants of its own

Source page: https://510kreport.com/device/K001869
Methodology: https://510kreport.com/methodology