Cleared Traditional

K222450 - LVIS NeuroMatch (FDA 510(k) Clearance)

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

K222450 · LVIS Corporation · Neurology device
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Jun 2023
Decision
298d
Days
Class 2
Risk

K222450 is an FDA 510(k) clearance for the LVIS NeuroMatch. Classified as Automatic Event Detection Software For Full-montage Electroencephalograph (product code OMB), Class II - Special Controls.

Submitted by LVIS Corporation (Palo Alto, US). The FDA issued a Cleared decision on June 9, 2023 after a review of 298 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 LVIS Corporation devices

Submission Details

510(k) Number K222450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2022
Decision Date June 09, 2023
Days to Decision 298 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
150d slower than avg
Panel avg: 148d · This submission: 298d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OMB Automatic Event Detection Software For Full-montage Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Automatically Mark Or Identify Electroencephalograph Waveforms For Spikes, Electrographic Seizures, Seizure-like Events In Order To Aid In Identification Of Such Events And Help Review And Annotation Of Prolonged Eeg Traces; 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 Consultant

Veranex, Inc.
Zane Liu

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.

Regulatory Peers - OMB Automatic Event Detection Software For Full-montage Electroencephalograph

All 40
Devices cleared under the same product code (OMB) and FDA review panel - the closest regulatory comparables to K222450.
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Ceribell Seizure Detection Software
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Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
K242446 · Persyst Development Corporation · Jan 2025
NeuroMatch
K241390 · LVIS Corporation · Nov 2024