Cleared Traditional

K203616 - Brainsway Deep (DTMS) System (FDA 510(k) Clearance)

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

K203616 · Brainsway , Ltd. · Neurology device
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Apr 2021
Decision
127d
Days
Class 2
Risk

K203616 is an FDA 510(k) clearance for the Brainsway Deep (DTMS) System. Classified as Transcranial Magnetic Stimulation System For Smoking Cessation (product code QMD), Class II - Special Controls.

Submitted by Brainsway , Ltd. (Jerusalem, IL). The FDA issued a Cleared decision on April 16, 2021 after a review of 127 days - within the typical 510(k) review window.

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 Brainsway , Ltd. devices

Submission Details

510(k) Number K203616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2020
Decision Date April 16, 2021
Days to Decision 127 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
21d faster than avg
Panel avg: 148d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QMD Transcranial Magnetic Stimulation System For Smoking Cessation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5802
Definition Intended For Use As A Transcranial Magnetic Stimulation System For Neurological And Psychiatric Disorders And Conditions.
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 Regulatory 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.