# K140200: E-Shield Multi-Paired Subdermal Needle Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Neuroinvent, Inc.
- Decided: Jul 18, 2014 after 172 days
- Product code: GXZ (Electrode, Needle)
- Device class: 2
- Regulation: 21 CFR 882.1350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K870795 (1987). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022914: Rhythmlink International Subdermal Needle Electrodes, Rhythmlink International, LLC (2002) Summary page 1.

## Most influential descendants
- K142470: E-Shield Multi-paried Subdermal Needle Electrodes (2014), 0 descendants of its own

## Indications for use
2-Shield Multi-paired Subdermal Needle Electrodes are intended for use with recording and monitoring equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephagraph (EEG) and Nerve potential signals. The electrodes are sterile and for single patient use only.

Source page: https://510kreport.com/device/K140200
Methodology: https://510kreport.com/methodology