# K121347: Presson Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Rhythmlink International, LLC
- Decided: Jul 12, 2012 after 72 days
- Product code: GXZ (Electrode, Needle)
- Device class: 2
- Regulation: 21 CFR 882.1350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

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

## Recalls of this device
- Mar 22, 2012 · Class II · Z-0752-2013: Lag screw measurement is short (approximately 5 mm) when using current screw measuring device (p/n 101-00010) per the IO FIX Surgical Technique Rev C. which can lead to possible inappropriate implant 

## Indications for use
The PressOn Electrode is intended for use in the recording of the Electroencephalogram (EEG), Evoked Potential (EP), or as Ground and Reference in an EEG or EP recording.

Source page: https://510kreport.com/device/K121347
Methodology: https://510kreport.com/methodology