Cleared Traditional

K153353 - SANDMAN ELITE

K153353 is an FDA 510(k) clearance for SANDMAN ELITE, manufactured by Embla Systems. The device is a Class 2 Neurology device with product code OLZ cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K153353 · Embla Systems · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
216d
Days
Class 2
Risk

K153353 is an FDA 510(k) clearance for the SANDMAN ELITE. Classified as Automatic Event Detection Software For Polysomnograph With Electroencephalograph (product code OLZ), Class II - Special Controls.

Submitted by Embla Systems (Kanata, CA). The FDA issued a Cleared decision on June 23, 2016 after a review of 216 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 Embla Systems devices

FDA 510(k) Submission Details - K153353

510(k) Number K153353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2015
Decision Date June 23, 2016
Days to Decision 216 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
68d slower than avg
Panel avg: 148d · This submission: 216d
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 30
Devices cleared under the same product code (OLZ) and FDA review panel - the closest regulatory comparables to K153353.
REMbrandt
K163617 · Embla Systems · Apr 2017
EnsoSleep
K162627 · Ensodata, Inc. · Mar 2017
RemLogic
K162140 · Embla Systems · Dec 2016
Sleep Profiler
K153412 · Advanced Brain Monitoring, Inc. · Mar 2016
Sleepware G3
K142988 · Respironics, Inc. · Mar 2015
Zmachine
K142825 · Consolidated Research of Richmond, Inc. · Jan 2015