# K090277: Natus Sleepworks, Model 104017

- Pathway: 510(k) (Traditional)
- Applicant: Excel-Tech Ltd. (Xltek)
- Decided: Apr 19, 2011 after 804 days
- Product code: OLZ (Automatic Event Detection Software For Polysomnograph With 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.
8 later devices descend from it; 4 cite it directly.
0 of 9 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
- K173366: NicoletOne (2018), 3 descendants of its own
- K200878: Natus NeuroWorks (2020), 1 descendant of its own
- K153353: Sandman Elite (2016), 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

## 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 Sleepworks software works in conjunction with Connex, Trex or Netlink amplifiers intended for polysomnography studies. The software allows recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various sleep disorders and sleep related respiratory disorders. The Sleepwdrks allows: " Automated analysis of physiological signals that is intended for use only in adults. " Ani optional Audio / visual alert for user defined threshold onl calibrated DC input. These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance inl 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 welt as data ranges for trendled values; Sleep Works software 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/K090277
Methodology: https://510kreport.com/methodology