# K143433: Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm

- Pathway: 510(k) (Traditional)
- Applicant: Natus Manufacturing Limited
- Decided: Aug 28, 2015 after 270 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: 2 generations back to K961013 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112034: Teca Elite Disposable Concentric Needles, Carefusion 209, Inc. (2011) Summary page 5.

## Indications for use
DantecTM DCN Disposable Concentric Needle Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the stimulation/recording of biopotential signals including electromyograph (EMG) and nerve potential signals.

Source page: https://510kreport.com/device/K143433
Methodology: https://510kreport.com/methodology