Cleared Traditional

K212289 - NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar (FDA 510(k) Clearance)

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

K212289 · Neuronetics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
289d
Days
Class 2
Risk

K212289 is an FDA 510(k) clearance for the NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advance.... Classified as Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder (product code QCI), Class II - Special Controls.

Submitted by Neuronetics, Inc. (Malvern, US). The FDA issued a Cleared decision on May 6, 2022 after a review of 289 days - an extended review cycle.

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 Neuronetics, Inc. devices

Submission Details

510(k) Number K212289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2021
Decision Date May 06, 2022
Days to Decision 289 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
141d slower than avg
Panel avg: 148d · This submission: 289d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K212289.
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