# K153353: Sandman Elite

- Pathway: 510(k) (Traditional)
- Applicant: Embla Systems
- Decided: Jun 23, 2016 after 216 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: 1 generation back to K934599 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934599: Sandman, Melville Software, Ltd. (1994) Summary page 4.
- K090277: Natus Sleepworks, Model 104017, Excel-Tech Ltd. (Xltek) (2011) Summary page 4.

## Most influential descendants
- K182227: Esprit Nova (2019), 0 descendants of its own

## Indications for use
The Sandman Elite software is intended for Polysomnography studies on pediatric and adult patients, and allows recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various sleep disorders. The Sandman software also allows: •Sleep report templates 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; •An optional 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. The Sandman software is intended for use only by qualified and trained medical practitioners in research and clinical environments, who evaluate the software output with their clinical experience and judgment to provide diagnostic conclusions about the patient's condition.

Source page: https://510kreport.com/device/K153353
Methodology: https://510kreport.com/methodology