# K200878: Natus NeuroWorks

- Pathway: 510(k) (Traditional)
- Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
- Decided: May 18, 2020 after 46 days
- Product code: OMB (Automatic Event Detection Software For Full-Montage Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K875179 (1988). 51 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180421: Natus NeuroWorks, Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) (2018) Summary page 5.
- K173366: NicoletOne, Natus Neurology Incorporated (2018) Summary page 5.
- K080217: Component Neuromonitoring System, Moberg Research, Inc. (2008) Summary page 5.

## Most influential descendants
- K251881: HippoMind (v1.0) (2025), 0 descendants of its own

## Indications for use
Natus NeuroWorks is EEG software that displays physiological signals. The intended user of this product is a qualified medical practitioner trained in Electroencephalography who will exercise professional judgment in using the information. The NeuroWorks EEG software allows acquisition, display, archive, review and analysis of physiological signals. * The Seizure Detection component of NeuroWorks is intended to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage according to the standard 10/20 system. * The Spike Detection component of NeuroWorks is intended to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage according to the standard 10/20 system. + aEEG, Burst Suppression, Envelope, Alpha variability, Spectral Edge and Spectral Entropy trending functionalities included in NeuroWorks are intended to assist the user while monitoring the state of the brain. The automated event marking function of Neuroworks is not applicable to these analysis features. » NeuroWorks also includes the display of a quantitative EEG plot, Density Spectral Array (DSA), which is intended to help the user to monitor and analyze the EEG waveform. The automated event marking function of NeuroWorks is not applicable to DSA. » This device does not provide any diagnostic conclusion about the patient’s condition to the user.

Source page: https://510kreport.com/device/K200878
Methodology: https://510kreport.com/methodology