# K033999: Sedline with Frontal Psi

- Pathway: 510(k) (Special)
- Applicant: Physiometrix, Inc.
- Decided: Feb 6, 2004 after 44 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
Longest line of descent: 2 generations back to K001069 (2000). 2 ancestors in all.
60 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)
- K020671: PSA4000 Eeg Monitor with Frontal Psi, Physiometrix, Inc. (2002) Summary page 3.

## 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 Sedline System is indicated for use in the operating room (OR), intensive care unit (ICU), and clinical research laboratory. It is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents.

Source page: https://510kreport.com/device/K033999
Methodology: https://510kreport.com/methodology