# K182227: Esprit Nova

- Pathway: 510(k) (Traditional)
- Applicant: Neurozone Msh Incorporated
- Decided: Jan 17, 2019 after 154 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: 8 generations back to K962603 (1997). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153412: Sleep Profiler, Advanced Brain Monitoring, Inc. (2016) Summary page 4.
- K153353: Sandman Elite, Embla Systems (2016) Summary page 4.

## Indications for use
Esprit Nova is a software-only product intended to assist a physician in the diagnostic evaluation of sleep quality and sleep disordered breathing in adults only. Esprit Nova analyzes the physiological signals and automatically scores sleep events; including the stages of sleep, microarousals, snoring, periodic limb movements, desaturations and sleep disordered breathing events apneas, hypopneas, and respiratory event related arousals). This device is to be used under the supervision of a physician. The device does not provide any diagnostic conclusion about the patient's condition.

Source page: https://510kreport.com/device/K182227
Methodology: https://510kreport.com/methodology