Cleared Traditional

K160703 - NeuroStar TMS Therapy System (FDA 510(k) Clearance)

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

K160703 · Neuronetics, Inc. · Neurology device

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Jun 2016

Decision

88d

Days

Class 2

Risk

K160703 is an FDA 510(k) clearance for the NeuroStar TMS Therapy System. 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 June 10, 2016 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Neuronetics, Inc. devices

Submission Details

510(k) Number	K160703 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 14, 2016
Decision Date	June 10, 2016
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

60d faster than avg

Panel avg: 148d · This submission: 88d

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.