Cleared Special

K180421 - Natus NeuroWorks

K180421 is an FDA 510(k) clearance for Natus NeuroWorks, manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). The device is a Class 2 Neurology device with product code OMB cleared through the Special 510(k) pathway after a 26-day FDA review.

K180421 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Neurology device
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Mar 2018
Decision
26d
Days
Class 2
Risk

K180421 is an FDA 510(k) clearance for the Natus NeuroWorks. Classified as Automatic Event Detection Software For Full-montage Electroencephalograph (product code OMB), Class II - Special Controls.

Submitted by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) (Oakville, CA). The FDA issued a Cleared decision on March 14, 2018 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) devices

FDA 510(k) Submission Details - K180421

510(k) Number K180421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2018
Decision Date March 14, 2018
Days to Decision 26 days
Submission Type Special
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
122d faster than avg
Panel avg: 148d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

OMB Device Classification - Class 2, Special Controls

Product Code OMB Automatic Event Detection Software For Full-montage Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Automatically Mark Or Identify Electroencephalograph Waveforms For Spikes, Electrographic Seizures, Seizure-like Events In Order To Aid In Identification Of Such Events And Help Review And Annotation Of Prolonged Eeg Traces; All Output Subject To Verification By 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 Peers - OMB Automatic Event Detection Software For Full-montage Electroencephalograph

All 22
Devices cleared under the same product code (OMB) and FDA review panel - the closest regulatory comparables to K180421.
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EEG SPIKE AND EVENT DETECTOR MODULE
K002332 · Excel Tech. , Ltd. · Oct 2000