Cleared Traditional

K162627 - EnsoSleep

K162627 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 192-day FDA review.

K162627 · Ensodata, Inc. · Neurology device
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Mar 2017
Decision
192d
Days
Class 2
Risk

K162627 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 March 31, 2017 after a review of 192 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 - K162627

510(k) Number K162627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2016
Decision Date March 31, 2017
Days to Decision 192 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 148d · This submission: 192d
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 20
Devices cleared under the same product code (OLZ) and FDA review panel - the closest regulatory comparables to K162627.
Nox Sleep System
K192469 · Nox Medical · Nov 2019
Esprit Nova
K182227 · Neurozone Msh Incorporated · Jan 2019
NicoletOne
K173366 · Natus Neurology Incorporated · Jul 2018
Sleepware G3
K142988 · Respironics, Inc. · Mar 2015
ALICE 5
K040595 · Respironics, Inc. · Mar 2004
SENSORMEDICS 4000 SERIES SLEEP SYSTEM
K915856 · Sensor Medics Corp. · Oct 1992