# K213007: Cerebra Sleep System

- Pathway: 510(k) (Traditional)
- Applicant: Cerebra Medical, Ltd.
- Decided: Jul 6, 2022 after 289 days
- Product code: OLV (Standard 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 K873535 (1987). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152040: X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29), Advanced Brain Monitoring, Inc. (2015) Summary page 4.
- K112102: Michele Sleep Scoring Systems, Younes Sleep Technologies (2011) Summary page 4.

## Indications for use
The Cerebra Sleep System is an integrated diagnostic platform that acquires, transmits, analyzes, and displays physiological signals from adult patients, and then provides for scoring (automatic and manual), editing, and generating reports. The system uses polysomnography (PSG) to record the electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), electromyogram (EMG), accelerometry, acoustic signals, nasal airflow, thoracic and abdomen respiratory effort, pulse rate, and oxyhemoglobin saturation, depending on the sleep study configuration. The Cerebra Sleep System is for prescription use in a home or healthcare facility. The Cerebra Sleep System is intended to be used as a support tool by physicians and PSG technologists to aid in the evaluation and diagnosis of sleep disorders. It is intended to provide sleep-related information that is interpreted by a qualified physician to render findings and/or diagnosis, but it does not directly generate a diagnosis.

Source page: https://510kreport.com/device/K213007
Methodology: https://510kreport.com/methodology