Cleared Traditional

BNA Platform (K202588) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence.

K202588 · Elminda, Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2020
Decision
90d
Days
Class 2
Risk

K202588 is an FDA 510(k) clearance for the BNA Platform. Classified as Normalizing Quantitative Electroencephalograph Software (product code OLU), Class II - Special Controls.

Submitted by Elminda, Ltd. (Herzliya, IL). The FDA issued a Cleared decision on December 7, 2020 after a review of 90 days - within the typical 510(k) review window.

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 Elminda, Ltd. devices

Submission Details

510(k) Number K202588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2020
Decision Date December 07, 2020
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Regulatory Consultant

Biologics Consulting
Donna-Bea Tillman

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT01460394 Completed Observational Industry-sponsored

Normative Data of Brain Network Activation in Adolescents and Young Adults

Establishment of Normative Data of Brain Network Activation (BNA) Using Evoked Response Potentials in Adolescents and Young Adults

64
Patients (actual)
1
Site
Condition studied Healthy Controls
Eligibility All sexes · 15 Years+ · Healthy volunteers accepted
Principal investigator Bradley D. Vince, D.O.
Sponsor ElMindA Ltd (industry)
Started 2011-10-01 → Primary completion 2012-04-01
Primary outcome
Functional networks of brain activity in healthy individuals measured using analysis of EEG Event Related Potential (ERP) data
Study completed - no results published. This trial concluded in 2012 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - OLU Normalizing Quantitative Electroencephalograph Software

All 11
Devices cleared under the same product code (OLU) and FDA review panel - the closest regulatory comparables to K202588.
NeuroField Analysis Suite
K240420 · Neurofield, Inc. · Sep 2024
iSyncBrain©-C
K222838 · iMediSync, Inc. · Mar 2023
BrainView QEEG Software
K212684 · Medeia, Inc. · Jan 2023
cortiQ PRO
K191432 · G.Tec Medical Engineering GmbH · Jan 2020
qEEG-Pro
K171414 · Brainmaster Technologies, Inc. · Jul 2018