# K162627: EnsoSleep

- Pathway: 510(k) (Traditional)
- Applicant: Ensodata, Inc.
- Decided: Mar 31, 2017 after 192 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.
9 later devices descend from it; 5 cite it directly.
0 of 44 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.

## Most influential descendants
- 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
- K253390: Somnum (Somnum) (2026), 0 descendants of its own

## Indications for use
EnsoSleep is intended for use for the diagnostic evaluation by a physician to assess sleep quality and as an aid for the diagnosis of sleep and respiratory related sleep disorders in adults only. EnsoSleep is a software-only medical 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, leg movements, and sleep disordered breathing events including obstructive apneas. All automatically scored events are subject to verification by a qualified clinician. Central apneas, mixed apneas, and hypopneas must be manually marked within records.

Source page: https://510kreport.com/device/K162627
Methodology: https://510kreport.com/methodology