Cleared Traditional

K260880 - SedLine Sedation Monitor

K260880 is the FDA 510(k) clearance for SedLine Sedation Monitor by Masimo Corporation. It is a Class 2 Anesthesiology device (product code OLW) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K260880 · Masimo Corporation · Anesthesiology device
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Jul 2026
Decision
115d
Days
Class 2
Risk

K260880 is an FDA 510(k) clearance for the SedLine Sedation Monitor. Classified as Index-generating Electroencephalograph Software (product code OLW), Class II - Special Controls.

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on July 10, 2026 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 882.1400 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Masimo Corporation devices

Submission Details

510(k) Number K260880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2026
Decision Date July 10, 2026
Days to Decision 115 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 140d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OLW Index-generating Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Analyze Electrical Activity Of The Brain By Transformation Of Electroencephalograph Signals Into A Dimensionless Index Number For Use And Interpretation By A Qualified User.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - OLW Index-generating Electroencephalograph Software

All 12
Devices cleared under the same product code (OLW) and FDA review panel - the closest regulatory comparables to K260880.
BIS™ Advance Monitoring System
K230693 · Covidien, LLC · Feb 2024
Brain Anesthesia Response Monitor (Bar Monitor)
K213273 · Cortical Dynamics , Ltd. · Sep 2023
Masimo SedLine Sedation Monitor and Accessories
K203113 · Masimo Corporation · Feb 2022
NeuroSENSE Monitoring System, Model NS-901
K202621 · Neurowave Systems, Inc. · Aug 2021
SedLine Sedation Monitor
K172890 · Masimo Corporation · Jan 2018
MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
K061907 · Ge Healthcare · Mar 2008