# K233438: SleepStageML

- Pathway: 510(k) (Traditional)
- Applicant: Beacon Biosignals, Inc.
- Decided: Mar 8, 2024 after 147 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). 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)
- K153412: Sleep Profiler, Advanced Brain Monitoring, Inc. (2016) Summary page 5.

## Indications for use
SleepStageML is intended for assisting the diagnostic evaluation by a qualified clinician to assess sleep quality from level 1 polysomnography (PSG) recordings in a clinical environment in patients aged 18 and older. SleepStageML is a software-only medical device to be used to analyze physiological signals and automatically score sleep stages. All outputs are subject to review by a qualified clinician.

Source page: https://510kreport.com/device/K233438
Methodology: https://510kreport.com/methodology