# K172890: SedLine Sedation Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Jan 26, 2018 after 126 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: 17 generations back to K962603 (1997). 77 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 83 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140188: Masimo Root Monitoring System, Masimo Corporation (2014) Summary page 4.

## Most influential descendants
- K223574: IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066) (2023), 2 descendants of its own
- K203113: Masimo SedLine Sedation Monitor and Accessories (2022), 1 descendant of its own
- K260880: SedLine Sedation Monitor (2026), 0 descendants of its own
- K251146: IntelliVue Patient monitors MX400, MX450, MX500, MX550 (2025), 0 descendants of its own
- K250453: IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500) (2025), 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 system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents. The agents include: Alfentanil, Desflurane, Fentanyl, Isoflurane, Nitrous Oxide, Propofol, Remifentanil, and Sevoflurane. The SedLine Sedation Monitor is intended for use with adult patients (18 years of age and older) in the operating room (OR), intensive care unit (ICU), and clinical research laboratory.

Source page: https://510kreport.com/device/K172890
Methodology: https://510kreport.com/methodology