Cleared Traditional

K251550 - NX01 (NX01) (FDA 510(k) Clearance)

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

K251550 · Naox Technologies Sas · Neurology device
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Nov 2025
Decision
188d
Days
Class 2
Risk

K251550 is an FDA 510(k) clearance for the NX01 (NX01). Classified as Reduced- Montage Standard Electroencephalograph (product code OMC), Class II - Special Controls.

Submitted by Naox Technologies Sas (Paris, FR). The FDA issued a Cleared decision on November 25, 2025 after a review of 188 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 Naox Technologies Sas devices

Submission Details

510(k) Number K251550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2025
Decision Date November 25, 2025
Days to Decision 188 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
40d slower than avg
Panel avg: 148d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 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 K251550.
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
SignalNED System (Model RE)
K242306 · Forest Devices, Inc. · Sep 2024
REMI Remote EEG Monitoring System
K230933 · Epitel, Inc. · Jun 2023