Cleared Special

K231350 - OCD MT Cap (85-00397-000) (FDA 510(k) Clearance)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K231350 · Neuronetics · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2023
Decision
30d
Days
Class 2
Risk

K231350 is an FDA 510(k) clearance for the OCD MT Cap (85-00397-000). Classified as Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder (product code QCI), Class II - Special Controls.

Submitted by Neuronetics (Malvern, US). The FDA issued a Cleared decision on June 8, 2023 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5802 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Neuronetics devices

Submission Details

510(k) Number K231350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2023
Decision Date June 08, 2023
Days to Decision 30 days
Submission Type Special
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
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

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

All 8
Devices cleared under the same product code (QCI) and FDA review panel - the closest regulatory comparables to K231350.
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
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