Cleared Traditional

Onera SleepMap (SLEEPMAP)

K253668 · Onera B.V. · Neurology

Mar 2026

Decision

107d

Days

Class 2

Risk

About This 510(k) Submission

K253668 is an FDA 510(k) clearance for the Onera SleepMap (SLEEPMAP), a Automatic Event Detection Software For Polysomnograph With Electroencephalograph (Class II — Special Controls, product code OLZ), submitted by Onera B.V. (Eindhoven, NL). The FDA issued a Cleared decision on March 8, 2026, 107 days after receiving the submission on November 21, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K253668 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 21, 2025
Decision Date	March 08, 2026
Days to Decision	107 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OLZ — Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Automatically Mark Electroencephalograph And Polysomongraph Signals In Order To Aid In Identification Of Such Events And Annotation Of Prolonged Psg Traces; Automatically Calculate Simple Measures Obtained From Recorded Signals (e.g. Magnitude, Time, Frequency And Simple Statistical Measures Of Marked Events); All Output Subject To Verification By Qualified User