# K090019: Natus Neuroworks, Model 104196

- Pathway: 510(k) (Traditional)
- Applicant: Natus Medical, Inc.
- Decided: Feb 22, 2010 after 416 days
- Product code: OMB (Automatic Event Detection Software For Full-Montage Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K180421: Natus NeuroWorks (2018), 2 descendants of its own
- K200878: Natus NeuroWorks (2020), 1 descendant of its own
- K251881: HippoMind (v1.0) (2025), 0 descendants of its own
- K123665: Lifelines Ieeg (2013), 0 descendants of its own
- K120260: ICTA (2012), 0 descendants of its own

## Recalls of this device
- Dec 2, 2021 · Class II · Z-0661-2022: Tile kits that allow one to install and situate a video camera within a patient environment are not fitting properly in some domestic institution ceiling tile grids that have a thinner style grid fram

## Indications for use
The Neuroworks is EEG software that displays physiological signals. The intended User of this product is a qualified medical practitioner trained in Electroencephalography. This device is intended to be used by qualified medical practitioners 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. a The aEEG functionality included in Neuroworks is intended to monitor the state of the brain. The automated event marking function of Neuroworks is not applicable to aEEG. * Neuroworks also includes the display of aquantitative EEG plot, Compressed Spectrum Array (GSA), 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 GSA. This device does not provide any diagnostic conclusion about the patient's condition to the user.

Source page: https://510kreport.com/device/K090019
Methodology: https://510kreport.com/methodology