Cleared Traditional

K243185 - REMI Remote EEG Monitoring System

K243185 is an FDA 510(k) clearance for REMI Remote EEG Monitoring System, manufactured by Epitel. The device is a Class 2 Neurology device with product code OMC cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K243185 · Epitel · Neurology device
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Mar 2025
Decision
172d
Days
Class 2
Risk

K243185 is an FDA 510(k) clearance for the REMI Remote EEG Monitoring System. Classified as Reduced- Montage Standard Electroencephalograph (product code OMC), Class II - Special Controls.

Submitted by Epitel (Salt Lake City, US). The FDA issued a Cleared decision on March 21, 2025 after a review of 172 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 Epitel devices

FDA 510(k) Submission Details - K243185

510(k) Number K243185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2024
Decision Date March 21, 2025
Days to Decision 172 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
24d slower than avg
Panel avg: 148d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OMC Device Classification - Class 2, Special Controls

Product Code OMC Reduced- Montage Standard Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A User-specified And/or Sponsor-specified Locations With A Reduced Array (i.e. Less Than < 16) Of Electrodes
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 - OMC Reduced- Montage Standard Electroencephalograph

All 13
Devices cleared under the same product code (OMC) and FDA review panel - the closest regulatory comparables to K243185.
NX01 (NX01)
K251550 · Naox Technologies Sas · Nov 2025
SignalNED System (Model RE)
K251726 · Forest Devices, Inc. · Sep 2025
Natus BrainWatch System
K242930 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Nov 2024
QUEX ED
K232779 · Qx World, Ltd. · Oct 2024
SignalNED System (Model RE)
K242306 · Forest Devices, Inc. · Sep 2024
REMI Remote EEG Monitoring System
K230933 · Epitel, Inc. · Jun 2023