Cleared Traditional

SedLine Sedation Monitor (K172890) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence.

K172890 · Masimo Corporation · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
126d
Days
Class 2
Risk

K172890 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 January 26, 2018 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Masimo Corporation devices

Submission Details

510(k) Number K172890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2017
Decision Date January 26, 2018
Days to Decision 126 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 148d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02043938 Completed Interventional Industry-sponsored

Improving Information Extraction From EEG on Cerebral Anesthetic Drug Effects

'Study of the Cerebral Effects of Sevoflurane, Propofol and Remifentanil as Measured by the Spontaneous Electro-encephalogram'

46
Patients (actual)
1
Site
Other
Purpose
Open label
Masking
Condition studied Anesthesia
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor Masimo Corporation (industry)
Started 2013-12-16 → Primary completion 2015-06-04
Primary outcome
Patient State Index (PSI) Comparison, Baseline and Emax
View full study on ClinicalTrials.gov

Regulatory Peers - OLW Index-generating Electroencephalograph Software

All 7
Devices cleared under the same product code (OLW) and FDA review panel - the closest regulatory comparables to K172890.
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
MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
K061907 · Ge Healthcare · Mar 2008
DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES
K052145 · Ge Healthcare · Aug 2005
DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
K050835 · Ge Healthcare · May 2005