Cleared Traditional

K182227 - Esprit Nova

K182227 is an FDA 510(k) clearance for Esprit Nova, manufactured by Neurozone Msh Incorporated. The device is a Class 2 Neurology device with product code OLZ cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K182227 · Neurozone Msh Incorporated · Neurology device
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Jan 2019
Decision
154d
Days
Class 2
Risk

K182227 is an FDA 510(k) clearance for the Esprit Nova. Classified as Automatic Event Detection Software For Polysomnograph With Electroencephalograph (product code OLZ), Class II - Special Controls.

Submitted by Neurozone Msh Incorporated (Dundas, CA). The FDA issued a Cleared decision on January 17, 2019 after a review of 154 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 Neurozone Msh Incorporated devices

FDA 510(k) Submission Details - K182227

510(k) Number K182227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2018
Decision Date January 17, 2019
Days to Decision 154 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
6d slower than avg
Panel avg: 148d · This submission: 154d
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 32
Devices cleared under the same product code (OLZ) and FDA review panel - the closest regulatory comparables to K182227.
EnsoSleep
K210034 · Ensodata, Inc. · Jun 2021
Sleepware G3
K202142 · Respironics, Inc. · Oct 2020
Nox Sleep System
K192469 · Nox Medical · Nov 2019
NicoletOne
K173366 · Natus Neurology Incorporated · Jul 2018
REMbrandt
K163617 · Embla Systems · Apr 2017
EnsoSleep
K162627 · Ensodata, Inc. · Mar 2017