# K210034: EnsoSleep

- Pathway: 510(k) (Traditional)
- Applicant: Ensodata, Inc.
- Decided: Jun 16, 2021 after 161 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: 9 generations back to K962603 (1997). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162627: EnsoSleep, Ensodata, Inc. (2017) Summary page 4.

## Indications for use
EnsoSleep is intended for use in the diagnostic evaluation by a physician to assess sleep quality and as an aid for physicians in the diagnosis of sleep disorders and respiratory related sleep disorders in pediatric and adult patients as follows: * Pediatric patients 13 years and older with polysomnography (PSG) tests obtained in a Hospital or Sleep Clinic * Adult patients with PSGs obtained in a Hospital or Sleep Clinic * Adult patients with Home Sleep Tests 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 (OSA), central sleep apneas (CSA), and hypopneas. All automatically scored events and physiological signals which are retrieved, analyzed, displayed, and summarized are subject to verification by a qualified clinician. Central sleep apneas (CSA) should be manually reviewed and modified as appropriate by a clinician. All events can be manually marked or edited within records during review. Photoplethysmography (PPG) total sleep time is not intended for use when electroencephalograph (EEG) data is recorded. PPG total sleep time is not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted.

Source page: https://510kreport.com/device/K210034
Methodology: https://510kreport.com/methodology