# K120494: Disposable Adhesive Surface Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Spes Medica Srl
- Decided: Jun 11, 2012 after 115 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: 2 generations back to K941799 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052188: Cutaneous Electrode, Rhythmlink International, LLC (2005) Summary page 1.
- K941799: Disposable Cutaneous Electrodes, Bio-Logic Systems Corp. (1995) Summary page 1.
- K062198: Sunspots Pre-Gelled Surface Electrodes, Axon Systems, Inc. (2006) Summary page 1.

## Indications for use
Spes Medica Disposable Adhesive Surface Electrodes are intended for use with electrodiagnostic or neurological monitoring equipment for the recording of electrophysiological activity and for electrical stimulation. The electrodes are non-sterile and for single patient use only.

Source page: https://510kreport.com/device/K120494
Methodology: https://510kreport.com/methodology