Cleared Traditional

Deep Transcranial Magnetic Stimulation (DTMS) System (K210201) - FDA 510(k) Clearance

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

K210201 · Brainsway , Ltd. · Neurology device
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Aug 2021
Decision
204d
Days
Class 2
Risk

K210201 is an FDA 510(k) clearance for the Deep Transcranial Magnetic Stimulation (DTMS) System. Classified as Transcranial Magnetic Stimulator (product code OBP), Class II - Special Controls.

Submitted by Brainsway , Ltd. (Jerusalem, IL). The FDA issued a Cleared decision on August 17, 2021 after a review of 204 days - an extended review cycle.

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

Submission Details

510(k) Number K210201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2021
Decision Date August 17, 2021
Days to Decision 204 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
56d slower than avg
Panel avg: 148d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

A. Stein-Regulatort Affairs Consulting , Ltd.
Ahava Stein

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K210201.
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
K213543 · Neuronetics, Inc. · Dec 2021
ALTMS Magnetic Stimulation Therapy System
K202537 · Remed Co., Ltd. · Nov 2021
Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation
K211389 · Magstim Company, Ltd. · Sep 2021
Brainsway Deep TMS System
K203735 · Brainsway , Ltd. · Apr 2021
NeuroStar Advanced Therapy
K201158 · Neuronetics, Inc. · Nov 2020
HORIZON TMS Therapy System with Navigation
K183376 · Magstim Company, Ltd. · Apr 2019