# K083818: Universal Electrodes

- Pathway: 510(k) (Special)
- Applicant: Neurometrix, Inc.
- Decided: Jan 21, 2009 after 30 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K802637 (1980). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081871: Universal Electrodes, Neurometrix, Inc. (2008) Summary page 1.
- K060584: NC-Stat, Neurometrix, Inc. (2006) Summary page 1.

## Indications for use
The NeuroMetnx UNIVERSAL Electrodes are intended for use with electrodiagnostic equipment for the recording of electrophysiological activity from peripheral nerves and muscles, and for peripheral nerve electrical stimulation UNIVERSAL Electrodes are non-sterile and are for single patient use only

Source page: https://510kreport.com/device/K083818
Methodology: https://510kreport.com/methodology