# K203113: Masimo SedLine Sedation Monitor and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Feb 25, 2022 after 498 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: 18 generations back to K962603 (1997). 78 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 80 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172890: SedLine Sedation Monitor, Masimo Corporation (2018) Summary page 4.

## Most influential descendants
- K260880: SedLine Sedation Monitor (2026), 0 descendants of its own

## Indications for use
The SedLine® Sedation Monitor is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The SedLine® Sedation Monitor is indicated for adult and pediatric patients (1 year of age and older) in the operating room (OR), intensive care unit (ICU), and clinical research laboratory. The system includes the Patient State Index (PSi), a proprietary computed EEG variable that is related to the effect of anesthetic agents. The PSi is indicated for use on adults sedated with the following agents: Alfentanil, Desflurane, Fentanyl, Isoflurane, Nitrous Oxide, Propofol, Remifentanil, and Sevoflurane. The PSi is not indicated for use in the pediatric population and is not displayed when using the pediatric sensors. The SedLine® is only to be used with Masimo SedLine® sensors and cables. The use of any other sensor or cable is neither supported nor recommended by Masimo and could give erroneous results. The RD SedLine Pediatric Sensor electrodes are applied directly to the patient’s skin to enable the recording of electrophysiological signals (e.g., EEG). The RD SedLine Pediatric Sensors are indicated for pediatric patients (1 to 17 years).

Source page: https://510kreport.com/device/K203113
Methodology: https://510kreport.com/methodology