Cleared Traditional

K253668 - Onera SleepMap (SLEEPMAP) (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence.

K253668 · Onera B.V. · Neurology device
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Optimized for regulatory review, auditing and printing
Mar 2026
Decision
107d
Days
Class 2
Risk

K253668 is an FDA 510(k) clearance for the Onera SleepMap (SLEEPMAP). Classified as Automatic Event Detection Software For Polysomnograph With Electroencephalograph (product code OLZ), Class II - Special Controls.

Submitted by Onera B.V. (Eindhoven, NL). The FDA issued a Cleared decision on March 8, 2026 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Onera B.V. devices

Submission Details

510(k) Number K253668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 148d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Device Class Class 2 - 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
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT05310708 Unknown Interventional Industry-sponsored

Validation Study of a Patch-based PSG System

300
Patients (est.)
7
Sites
Diagnostic
Purpose
Open label
Masking
Condition studied Sleep Disorder
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Hartmut Schneider
Sponsor Onera BV (industry)
Started 2022-01-21 → Primary completion 2024-06-21
Primary outcome
EOG left
Secondary outcome
Total Sleep Time
View full study on ClinicalTrials.gov

Regulatory Peers - OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph

All 35
Devices cleared under the same product code (OLZ) and FDA review panel - the closest regulatory comparables to K253668.
Hypnos (369054-200)
K250851 · Cadwell Industries, Inc. · Dec 2025
DeepRESP
K252330 · Nox Medical Ehf · Nov 2025
NEAT 001
K250058 · Brain Electrophysiology Laboratory Company, LLC · Apr 2025
DeepRESP
K241960 · Nox Medical Ehf · Mar 2025
Dreem 3S
K242094 · Beacon Biosignals, Inc. · Nov 2024
SleepStageML
K233438 · Beacon Biosignals, Inc. · Mar 2024