# K153412: Sleep Profiler

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Brain Monitoring, Inc.
- Decided: Mar 14, 2016 after 110 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: 7 generations back to K962603 (1997). 33 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130007: Sleep Profiler, Advanced Brain Monitoring, Inc. (2013) Summary page 4.

## Most influential descendants
- 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
- K223922: Somnum (V.1.1.2.) (2023), 1 descendant of its own
- K261747: Report Studio (2026), 0 descendants of its own

## Indications for use
Sleep Profiler is intended for use for the diagnostic evaluation by a physician to assess sleep quality and score sleep disordered breathing events 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, snoring and sleep disordered breathing events (obstructive apneas, hypopneas and respiratory event related arousals). Central and mixed apneas can be manually marked within the records.

Source page: https://510kreport.com/device/K153412
Methodology: https://510kreport.com/methodology