# K103103: Presson Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Persyst Development Corp.
- Decided: Dec 8, 2011 after 414 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: 4 generations back to K870795 (1987). 20 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022914: Rhythmlink International Subdermal Needle Electrodes, Rhythmlink International, LLC (2002) Summary page 2.

## Most influential descendants
- K130220: MR Conditional Presson Electrode (2013), 1 descendant of its own
- K190801: PressOn Electrode Headset (2019), 0 descendants of its own

## Indications for use
The PressOnTM electrode is intended for use in the recording of the electroencephalogram (EEG), the evoked potential (EP), or as ground and reference in an EEG or EP recording.

Source page: https://510kreport.com/device/K103103
Methodology: https://510kreport.com/methodology