# K253581: Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005)

- Pathway: 510(k) (Traditional)
- Applicant: Technomed Europe
- Decided: Mar 15, 2026 after 118 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
Longest line of descent: 3 generations back to K870795 (1987). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990015: Electrode Needles, Technomed Europe (1999) Summary page 5.

## Indications for use
Disposable Concentric Needle Electrodes are intended for use with recording, monitoring equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyography (EMG) and nerve potential signal.

Source page: https://510kreport.com/device/K253581
Methodology: https://510kreport.com/methodology