Cleared Traditional

K260402 - MeRT System

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

K260402 is an FDA 510(k) clearance for the MeRT System.

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. 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 SIG
Device Class -

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