# K081871: Universal Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Neurometrix, Inc.
- Decided: Sep 29, 2008 after 90 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: 5 generations back to K802637 (1980). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062198: Sunspots Pre-Gelled Surface Electrodes, Axon Systems, Inc. (2006) Summary page 1.
- K060584: NC-Stat, Neurometrix, Inc. (2006) Summary page 1.

## Most influential descendants
- K083818: Universal Electrodes (2009), 0 descendants of its own

## Indications for use
The NeuroMetrix 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/K081871
Methodology: https://510kreport.com/methodology