Cleared Traditional

K171184 - Persyst Mobile App (FDA 510(k) Clearance)

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

K171184 · Persyst Development Corporation · Neurology device
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Sep 2017
Decision
150d
Days
Class 2
Risk

K171184 is an FDA 510(k) clearance for the Persyst Mobile App. 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 September 21, 2017 after a review of 150 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 K171184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2017
Decision Date September 21, 2017
Days to Decision 150 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 148d · This submission: 150d
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 K171184.
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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