Cleared Traditional

K240420 - NeuroField Analysis Suite (FDA 510(k) Clearance)

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

K240420 · Neurofield, Inc. · Neurology device
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Sep 2024
Decision
220d
Days
Class 2
Risk

K240420 is an FDA 510(k) clearance for the NeuroField Analysis Suite. Classified as Normalizing Quantitative Electroencephalograph Software (product code OLU), Class II - Special Controls.

Submitted by Neurofield, Inc. (Bishop, US). The FDA issued a Cleared decision on September 20, 2024 after a review of 220 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 Neurofield, Inc. devices

Submission Details

510(k) Number K240420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2024
Decision Date September 20, 2024
Days to Decision 220 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
72d slower than avg
Panel avg: 148d · This submission: 220d
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 Consultant

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Tom Renner

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.