# K020670: Model 4310 PSARRAY2 Eeg Electrode

- Pathway: 510(k) (Special)
- Applicant: Physiometrix, Inc.
- Decided: Oct 8, 2002 after 221 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
No predicates in its family tree.
60 later devices descend from it; 1 cites it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K01055: Model 4300, PSArray EEG Electrode. Number could not be read Summary page 1.

## Most influential descendants
- K051874: Sedline Sedation Monitor with Frontal Psi and Sedtrace Eeg Electrose Set (2005), 59 descendants of its own
- K140188: Masimo Root Monitoring System (2014), 58 descendants of its own
- K142394: Masimo Root Monitoring System and Accesories (2014), 51 descendants of its own
- K151644: Masimo Root Vital Signs Monitoring System and Accessories (2016), 24 descendants of its own
- K150314: Masimo MightySat Rx Fingertip Pulse Oximeter (2015), 24 descendants of its own

## Indications for use
The Physiometrix PSArray EEG Electrode is applied directly to the patient's skin to enable recording of electrophysiologic (such as EEG) signals.

Source page: https://510kreport.com/device/K020670
Methodology: https://510kreport.com/methodology