# K253668: Onera SleepMap (SLEEPMAP)

- Pathway: 510(k) (Traditional)
- Applicant: Onera B.V.
- Decided: Mar 8, 2026 after 107 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 8.

## Indications for use
SleepMap is intended for use as an aid for physicians in the diagnosis of sleep and respiratory related disorders in adult patients (aged 18 and up), who have been prescribed a sleep study by their doctor. SleepMap is a software-only medical device to be used under the supervision of a clinician to analyze physiological signals and automatically score sleep study recordings, including the staging of sleep, detection of arousals, leg movements, desaturations, obstructive apneas and obstructive hypopneas. Respiratory event subtypes (central and mixed apneas; central hypopneas), RERA, Cheyne Stokes Breathing, Snoring Events, and Arrhythmia Events are not automatically detected and must be manually marked within records. All automatically detected stages and detected events can be manually marked or edited within records during review. All automatically scored stages, detected events and physiological signals which are retrieved, analyzed, displayed, and summarized are subject to verification by a qualified clinician.

Source page: https://510kreport.com/device/K253668
Methodology: https://510kreport.com/methodology