# K261442: Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array

- Pathway: 510(k) (Abbreviated)
- Applicant: Cadwell Industries, Inc.
- Decided: Jun 26, 2026 after 57 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: 3 generations back to K942921 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072016: Cup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes Silver/Silver Chloride Reusable, Technomed Europe (2007) Summary page 5.

## Indications for use
Charlotte Surface Electrode Arrays are indicated for non-invasive use with recording and monitoring equipment to acquire physiological electrical signals from Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials (EP).

Source page: https://510kreport.com/device/K261442
Methodology: https://510kreport.com/methodology