# K173366: NicoletOne

- Pathway: 510(k) (Traditional)
- Applicant: Natus Neurology Incorporated
- Decided: Jul 20, 2018 after 267 days
- Product code: OLZ (Automatic Event Detection Software For Polysomnograph With 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: 7 generations back to K875179 (1988). 48 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012976: Twin Plus, Grass-Telefactor Divison (2002) Summary page 4.
- K080217: Component Neuromonitoring System, Moberg Research, Inc. (2008) Summary page 4.
- K090277: Natus Sleepworks, Model 104017, Excel-Tech Ltd. (Xltek) (2011) Summary page 4.

## Most influential descendants
- K200878: Natus NeuroWorks (2020), 1 descendant of its own
- K251881: HippoMind (v1.0) (2025), 0 descendants of its own
- K190760: Cadwell Bolt Software (2019), 0 descendants of its own

## Indications for use
The NicoletOne EEG/PSG software performs recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various neurological disorders, sleep disorders and sleep related respiratory disorders. It is intended to monitor the state of the brain by recording and displaying EEG signals and can receive and display a variety of third party signals such as ECG, EMG, Oxygen Saturation or Respiration for patients of all ages. NicoletOne software allows: • Automated analysis of physiological signals that is intended for use only in adults. • An optional Audio/visual alert for user defined threshold on calibrated DC input. These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units. • Sleep report templates are provided which summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values. This device does not provide any diagnostic conclusion about the patient's condition and is intended to be used only by qualified and trained medical practitioners, in research and clinical environments.

Source page: https://510kreport.com/device/K173366
Methodology: https://510kreport.com/methodology