Cleared Special

NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health (K222230) - FDA 510(k) Clearance

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

K222230 · Neuronetics, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Aug 2022
Decision
30d
Days
Class 2
Risk

K222230 is an FDA 510(k) clearance for the NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, N.... Classified as Transcranial Magnetic Stimulator (product code OBP), Class II - Special Controls.

Submitted by Neuronetics, Inc. (Malvern, US). The FDA issued a Cleared decision on August 24, 2022 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5805 - 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, Inc. devices

Submission Details

510(k) Number K222230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2022
Decision Date August 24, 2022
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 OBP Transcranial Magnetic Stimulator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5805
Definition A Transcranial Magnetic Stimulator Is A Device That Delivers Brief Duration, Rapidly Alternating, Or Pulsed, Magnetic Fields To Induce Electrical Currents That Are Directed At Spatially Discrete Regions Of The Cerebral Cortex For The Treatment Of Major Depressive Disorder.
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 - OBP Transcranial Magnetic Stimulator

All 47
Devices cleared under the same product code (OBP) and FDA review panel - the closest regulatory comparables to K222230.
Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+
K222171 · Magstim Company, Ltd. · Jan 2023
Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K
K220177 · Magnus Medical, Inc. · Sep 2022
BrainsWay Deep TMS System
K220819 · Brainsway , Ltd. · Aug 2022
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
K220127 · Neuronetics, Inc. · Jul 2022
ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System
K220625 · Remed Co., Ltd. · Apr 2022
BTL-995-rTMS
K212723 · BTL Industries, Inc. · Mar 2022