Cleared Traditional

K242306 - SignalNED System (Model RE) (FDA 510(k) Clearance)

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

K242306 · Forest Devices, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2024
Decision
30d
Days
Class 2
Risk

K242306 is an FDA 510(k) clearance for the SignalNED System (Model RE). Classified as Reduced- Montage Standard Electroencephalograph (product code OMC), Class II - Special Controls.

Submitted by Forest Devices, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on September 4, 2024 after a review of 30 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Forest Devices, Inc. devices

Submission Details

510(k) Number K242306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2024
Decision Date September 04, 2024
Days to Decision 30 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 Consultant

Third Party Review Group, LLC
Dave Yungvirt

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OMC Reduced- Montage Standard Electroencephalograph

All 27
Devices cleared under the same product code (OMC) and FDA review panel - the closest regulatory comparables to K242306.
NX01 (NX01)
K251550 · Naox Technologies Sas · Nov 2025
SignalNED System (Model RE)
K251726 · Forest Devices, Inc. · Sep 2025
REMI Remote EEG Monitoring System
K243185 · Epitel · Mar 2025
Natus BrainWatch System
K242930 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Nov 2024
QUEX ED
K232779 · Qx World, Ltd. · Oct 2024
REMI Remote EEG Monitoring System
K230933 · Epitel, Inc. · Jun 2023