# K120450: Sleep Profiler

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Brain Monitoring, Inc.
- Decided: Sep 19, 2012 after 218 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: 5 generations back to K962603 (1997). 31 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112514: Apnea Risk Evaluation System (Ares), Advanced Brain Monitoring, Inc. (2012) Summary page 1.
- K112102: Michele Sleep Scoring Systems, Younes Sleep Technologies (2011) Summary page 1.

## Most influential descendants
- K130007: Sleep Profiler (2013), 14 descendants of its own
- K153412: Sleep Profiler (2016), 13 descendants of its own
- K162627: EnsoSleep (2017), 9 descendants of its own
- K221179: SomnoMetry (2022), 3 descendants of its own
- K241288: Noxturnal Web (2024), 2 descendants of its own

## Indications for use
Sleep Profiler is intended for the diagnostic evaluation by a physician to assess sleep quality in adults only. The Sleep Profiler is a software-only device to be used under the supervision of a clinician to analyze physiological signals and automatically score sleep study results, including the staging of sleep, detection of arousals and snoring.

Source page: https://510kreport.com/device/K120450
Methodology: https://510kreport.com/methodology