# K190801: PressOn Electrode Headset

- Pathway: 510(k) (Traditional)
- Applicant: Rhythmlink International, LLC
- Decided: Jul 10, 2019 after 103 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: 6 generations back to K870795 (1987). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130220: MR Conditional Presson Electrode, Rhythmlink International, LLC (2013) Summary page 4.

## Indications for use
The PressOn™ Electrode Headset is intended for use in the recording of electroencephalogram (EEG), evoked potential (EP), or as a ground and reference in an EEG or EP recording. The device is provided sterile for single patient use only.

Source page: https://510kreport.com/device/K190801
Methodology: https://510kreport.com/methodology