Cleared Traditional

K231779 - REMI AI Discrete Detection Module (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence.

K231779 · Epitel, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Jan 2024
Decision
201d
Days
Class 2
Risk

K231779 is an FDA 510(k) clearance for the REMI AI Discrete Detection Module. Classified as Automatic Event Detection Software For Full-montage Electroencephalograph (product code OMB), Class II - Special Controls.

Submitted by Epitel, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on January 3, 2024 after a review of 201 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: Incremental AI imaging tool. Moderate-to-high equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Epitel, Inc. devices

Submission Details

510(k) Number K231779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2023
Decision Date January 03, 2024
Days to Decision 201 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 148d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. PCCP authorized - AI/SaMD pathway.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03583957 Unknown Interventional Industry-sponsored

A Wireless EEG Patch for Continuous Electrographic Monitoring

750
Patients (est.)
3
Sites
Diagnostic
Purpose
Open label
Masking
Condition studied Epilepsy
Study design Single group
Eligibility All sexes · 5 Years+
Sponsor Epitel, Inc. (industry)
Started 2018-05-08 → Primary completion 2026-04-30
Primary outcome
Single channel EEG coherence
View full study on ClinicalTrials.gov

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 K231779.
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
Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
K242446 · Persyst Development Corporation · Jan 2025
NeuroMatch
K241390 · LVIS Corporation · Nov 2024