Cleared Traditional

NeuroStar Advanced Therapy (K201158) - FDA 510(k) Clearance

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

K201158 · Neuronetics, Inc. · Neurology device
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Nov 2020
Decision
204d
Days
Class 2
Risk

K201158 is an FDA 510(k) clearance for the NeuroStar Advanced Therapy. 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 November 20, 2020 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 Neuronetics, Inc. devices

Submission Details

510(k) Number K201158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2020
Decision Date November 20, 2020
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 Peers - OBP Transcranial Magnetic Stimulator

All 47
Devices cleared under the same product code (OBP) and FDA review panel - the closest regulatory comparables to K201158.
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
Deep Transcranial Magnetic Stimulation (DTMS) System
K210201 · Brainsway , Ltd. · Aug 2021
Brainsway Deep TMS System
K203735 · Brainsway , Ltd. · Apr 2021
HORIZON TMS Therapy System with Navigation
K183376 · Magstim Company, Ltd. · Apr 2019
Nexstim Navigated Brain Therapy (NBT) System 2
K182700 · Nexstim Plc · Mar 2019
HORIZON TMS Therapy System
K182853 · Magstim Company, Ltd. · Mar 2019