# K260880: SedLine Sedation Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Jul 10, 2026 after 115 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: 19 generations back to K962603 (1997). 79 ancestors in all.
No later device cites it as a predicate yet.
1 of 80 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203113: Masimo SedLine Sedation Monitor and Accessories, Masimo Corporation (2022) Summary page 5.

## 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 indicated for use on pediatrics 4 years and older when sedated with the following agents: Sevoflurane, Propofol. 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.

Source page: https://510kreport.com/device/K260880
Methodology: https://510kreport.com/methodology