Cleared Traditional

Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))

K252160 · Persyst Development, LLC · Neurology

Oct 2025

Decision

113d

Days

Class 2

Risk

About This 510(k) Submission

K252160 is an FDA 510(k) clearance for the Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)), a Automatic Event Detection Software For Full-montage Electroencephalograph (Class II — Special Controls, product code OMB), submitted by Persyst Development, LLC (Solana Beach, US). The FDA issued a Cleared decision on October 31, 2025, 113 days after receiving the submission on July 10, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K252160 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 10, 2025
Decision Date	October 31, 2025
Days to Decision	113 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Statement

Device Classification

Product Code	OMB — Automatic Event Detection Software For Full-montage Electroencephalograph
Device Class	Class II — 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