Cleared Traditional

iSyncBrain©-C (K222838) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K222838 · iMediSync, Inc. · Neurology device
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Mar 2023
Decision
177d
Days
Class 2
Risk

K222838 is an FDA 510(k) clearance for the iSyncBrain©-C. Classified as Normalizing Quantitative Electroencephalograph Software (product code OLU), Class II - Special Controls.

Submitted by iMediSync, Inc. (Seoul, KR). The FDA issued a Cleared decision on March 16, 2023 after a review of 177 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 iMediSync, Inc. devices

Submission Details

510(k) Number K222838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2022
Decision Date March 16, 2023
Days to Decision 177 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
29d slower than avg
Panel avg: 148d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OLU Normalizing Quantitative Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Post-hoc Statistical Analysis Of Electroencephalograph Signals With Comparison To A Normative Database For Interpretation By A 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 - OLU Normalizing Quantitative Electroencephalograph Software

Devices cleared under the same product code (OLU) and FDA review panel - the closest regulatory comparables to K222838.
NeuroField Analysis Suite
K240420 · Neurofield, Inc. · Sep 2024
BrainView QEEG Software
K212684 · Medeia, Inc. · Jan 2023
BNA Platform
K202588 · Elminda, Ltd. · Dec 2020
cortiQ PRO
K191432 · G.Tec Medical Engineering GmbH · Jan 2020
qEEG-Pro
K171414 · Brainmaster Technologies, Inc. · Jul 2018