Cleared Traditional

K242446 - Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) (FDA 510(k) Clearance)

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

K242446 · Persyst Development Corporation · Neurology device
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Jan 2025
Decision
159d
Days
Class 2
Risk

K242446 is an FDA 510(k) clearance for the Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)). Classified as Automatic Event Detection Software For Full-montage Electroencephalograph (product code OMB), Class II - Special Controls.

Submitted by Persyst Development Corporation (Solana Beach, US). The FDA issued a Cleared decision on January 22, 2025 after a review of 159 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 Persyst Development Corporation devices

Submission Details

510(k) Number K242446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2024
Decision Date January 22, 2025
Days to Decision 159 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 148d · This submission: 159d
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 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 K242446.
Ceribell Infant Seizure Detection Software
K252070 · Ceribell, Inc. · Nov 2025
Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
K252160 · Persyst Development, LLC · Oct 2025
Ceribell Seizure Detection Software
K241589 · Ceribell, Inc. · Apr 2025
autoSCORE (V 2.0.0)
K243743 · Holberg Eeg AS · Apr 2025
NeuroMatch
K241390 · LVIS Corporation · Nov 2024
REMI-AI Rapid Detection Module (REMI-AI RDM)
K240408 · Epitel, Inc. · Oct 2024