# K142470: E-Shield Multi-paried Subdermal Needle Electrodes

- Pathway: 510(k) (Special)
- Applicant: Neuroinvent, Inc.
- Decided: Nov 5, 2014 after 63 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: 5 generations back to K870795 (1987). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140200: E-Shield Multi-Paired Subdermal Needle Electrodes, Neuroinvent, Inc. (2014) Summary page 4.

## Indications for use
E-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/K142470
Methodology: https://510kreport.com/methodology