Cleared Special

Neuro Omega System, NeuroSmart System (K220553) - FDA 510(k) Clearance

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K220553 · Alpha Omega Engineering , Ltd. · Neurology device
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Sep 2022
Decision
200d
Days
Class 2
Risk

K220553 is an FDA 510(k) clearance for the Neuro Omega System, NeuroSmart System. Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Alpha Omega Engineering , Ltd. (Nof Hagalil (Nazareth Illit), IL). The FDA issued a Cleared decision on September 16, 2022 after a review of 200 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1330 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Alpha Omega Engineering , Ltd. devices

Submission Details

510(k) Number K220553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2022
Decision Date September 16, 2022
Days to Decision 200 days
Submission Type Special
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
52d slower than avg
Panel avg: 148d · This submission: 200d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GZL Electrode, Depth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1330
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 - GZL Electrode, Depth

All 15
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K220553.
SENSOSEEG Depth Electrodes
K213170 · Sensomedical Labs, Ltd. · Apr 2023
iCE-SG2 Subcutaneous Electrode Kit
K222706 · Ice Neurosystems, Inc. · Dec 2022
Evo® sEEG System
K222404 · Neuroone Medical Technologies Corp. · Oct 2022
DIXI Medical Microdeep Micro-Macro Depth Electrodes
K202087 · Dixi Medical · Nov 2021
Evo sEEG System
K211367 · Neuroone Medical Technologies Corp. · Sep 2021
iCE-SG Subcutaneous Electrode Arrays
K201678 · Ice Neurosystems, Inc. · Mar 2021