Cleared Traditional

K210034 - EnsoSleep

K210034 is an FDA 510(k) clearance for EnsoSleep, manufactured by Ensodata, Inc.. The device is a Class 2 Neurology device with product code OLZ cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K210034 · Ensodata, Inc. · Neurology device
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Jun 2021
Decision
161d
Days
Class 2
Risk

K210034 is an FDA 510(k) clearance for the EnsoSleep. Classified as Automatic Event Detection Software For Polysomnograph With Electroencephalograph (product code OLZ), Class II - Special Controls.

Submitted by Ensodata, Inc. (Madison, US). The FDA issued a Cleared decision on June 16, 2021 after a review of 161 days - an extended review cycle.

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 Ensodata, Inc. devices

FDA 510(k) Submission Details - K210034

510(k) Number K210034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2021
Decision Date June 16, 2021
Days to Decision 161 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
13d slower than avg
Panel avg: 148d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLZ Device Classification - Class 2, Special Controls

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

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

All 19
Devices cleared under the same product code (OLZ) and FDA review panel - the closest regulatory comparables to K210034.
Dreem 3S
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SOMNUM (V.1.1.2.)
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SomnoMetry
K221179 · Neumetry Medical, Inc. · Sep 2022
Sleepware G3
K202142 · Respironics, Inc. · Oct 2020
Nox Sleep System
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Esprit Nova
K182227 · Neurozone Msh Incorporated · Jan 2019