# K130220: MR Conditional Presson Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Rhythmlink International, LLC
- Decided: Jul 22, 2013 after 174 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: 5 generations back to K870795 (1987). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103103: Presson Electrode, Persyst Development Corp. (2011) Summary page 2.
- K121347: Presson Electrode, Rhythmlink International, LLC (2012) Summary page 1.

## Most influential descendants
- K190801: PressOn Electrode Headset (2019), 0 descendants of its own

## Indications for use
The MR Conditional PressOn Electrode is intended for use in the recording of the Electroencephalogram (EEG), the evoked potential (EP), or as a ground and reference in an EEG or EP recording. This device is provided sterile for Single Patient Use Only and may remain on the patient in a MRI environment under specific conditions.

Source page: https://510kreport.com/device/K130220
Methodology: https://510kreport.com/methodology