Cleared Traditional

K150298 - Entropy Module, E-ENTROPY-01

K150298 is an FDA 510(k) clearance for Entropy Module, manufactured by Ge Healthcare Filand OY. The device is a Class 2 Neurology device with product code OLW cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K150298 · Ge Healthcare Filand OY · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
279d
Days
Class 2
Risk

K150298 is an FDA 510(k) clearance for the Entropy Module, E-ENTROPY-01. Classified as Index-generating Electroencephalograph Software (product code OLW), Class II - Special Controls.

Submitted by Ge Healthcare Filand OY (Helsinki, FI). The FDA issued a Cleared decision on November 12, 2015 after a review of 279 days - an extended review cycle.

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 Ge Healthcare Filand OY devices

FDA 510(k) Submission Details - K150298

510(k) Number K150298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2015
Decision Date November 12, 2015
Days to Decision 279 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
131d slower than avg
Panel avg: 148d · This submission: 279d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLW Device Classification - Class 2, Special Controls

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 Neurology devices follow this clearance model.

Regulatory Consultant

GE Healthcare
JOEL KENT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OLW Index-generating Electroencephalograph Software

All 35
Devices cleared under the same product code (OLW) and FDA review panel - the closest regulatory comparables to K150298.
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
BIS INTERFACE FOR VITALOGIK PATIENT MONITORS
K083063 · Mennen Medical , Ltd. · Dec 2008
MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
K061907 · Ge Healthcare · Mar 2008
BIS EEG VISTA MONITOR SYSTEM AND BISX
K072286 · Aspect Medical Systems, Inc. · Nov 2007