SedLine Sedation Monitor— 510(k) K260880

Name: FDA 510(k) clearance K260880
Creator: U.S. Food and Drug Administration
Published: 2026-07-10

Substantially Equivalent

Masimo Corporation

FDA 510(k) clearance K260880 for SedLine Sedation Monitor, Substantially Equivalent on 2026-07-10. Applicant: Masimo Corporation. Device class: 2.

Summary

Masimo's SedLine Sedation Monitor is filed under OLW, index-generating electroencephalograph software. The record doesn't describe the index or the system's components.

Class II, 21 CFR 882.1400. The Anesthesiology review panel handled it as a Traditional 510(k), though the record lists Neurology as the classification panel.

Masimo filed from Irvine, California. Review took 115 calendar days (March 17 to July 10, 2026).

Clearance details

Applicant: Masimo Corporation
Product code: Product code OLW
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2026-03-17
Decision date: 2026-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.