# K001069: Model 4000 Eeg Monitor with Psi (PSA4000)

- Pathway: 510(k) (Traditional)
- Applicant: Physiometrix, Inc.
- Decided: Jun 30, 2000 after 88 days
- Product code: OLW (Index-Generating Electroencephalograph Software)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
62 later devices descend from it; 1 cites it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020671: PSA4000 Eeg Monitor with Frontal Psi (2002), 61 descendants of its own
- K033999: Sedline with Frontal Psi (2004), 60 descendants of its own
- 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

Source page: https://510kreport.com/device/K001069
Methodology: https://510kreport.com/methodology