Cleared Traditional

MeRT System (K260402) - FDA 510(k) Clearance

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

K260402 · Wave Neuroscience · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
117d
Days
Class 2
Risk

K260402 is an FDA 510(k) clearance for the MeRT System. Classified as Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder (product code QCI), Class II - Special Controls.

Submitted by Wave Neuroscience (Newport Beach, US). The FDA issued a Cleared decision on June 3, 2026 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5802 - 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 Wave Neuroscience devices

Submission Details

510(k) Number K260402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2026
Decision Date June 03, 2026
Days to Decision 117 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
31d faster than avg
Panel avg: 148d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QCI Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5802
Definition External Device That Uses Magnetic Fields To Induce Neural Activity In The Cerebral Cortex To Treat Neurological And Psychiatric Disorders And Conditions. It Is Not Intended For Applying Or Focusing Magnetic Fields Towards Brain Areas Outside Cerebral Cortex (e.g., Cerebellum).
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
NCT02990793 Completed Interventional Industry-sponsored

Clinical Trial to Evaluate the Safety and Efficacy of MeRT Treatment in Post-Traumatic Stress Disorder

A Prospective, Double Blind, Randomized, Sham-Controlled, Clinical Trial to Evaluate The Safety And Efficacy Of Biometrics-Guided Magnetic EEG Resonance Therapy (MeRT) Treatment Of Post-Traumatic Stress Disorder

158
Patients (actual)
8
Sites
Treatment
Purpose
Triple
Masking
Condition studied PostTraumatic Stress Disorder; Traumatic Brain Injury; Postconcussive Symptoms
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Kenneth Ramos, MD,PhD
Sponsor Wave Neuroscience (industry)
Started 2022-04-04 → Primary completion 2025-09-18 → Completed 2025-11-04
Primary outcome
Change in PTSD Symptoms
Study completed - no results published. This trial concluded in 2025 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - QCI Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder

All 9
Devices cleared under the same product code (QCI) and FDA review panel - the closest regulatory comparables to K260402.
Ultimate rTMS for OCD (M-series)
K243459 · Brain Ultimate, Inc. · Apr 2025
BTL-99-OC
K230657 · BTL Industries, Inc. · Feb 2024
CloudTMS Edge for OCD
K233742 · Teleemg, LLC · Dec 2023
OCD MT Cap (85-00397-000)
K231350 · Neuronetics · Jun 2023
CloudTMS for OCD
K221129 · Teleemg, LLC · Mar 2023
NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar
K212289 · Neuronetics, Inc. · May 2022