Cleared Traditional

K160703 - NeuroStar TMS Therapy System

K160703 is an FDA 510(k) clearance for NeuroStar TMS Therapy System, manufactured by Neuronetics, Inc.. The device is a Class 2 Neurology device with product code OBP cleared through the Traditional 510(k) pathway after a 88-day FDA review.

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

FDA 510(k) Submission Details - K160703

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 149d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OBP Device Classification - Class 2, Special Controls

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 68
Devices cleared under the same product code (OBP) and FDA review panel - the closest regulatory comparables to K160703.
Rapid2 Therapy System
K162935 · Magstim Company, Ltd. · Mar 2017
Neurosoft TMS
K160309 · Teleemg, LLC · Dec 2016
NeuroStar TMS Therapy System
K161519 · Neuronetics, Inc. · Sep 2016
MagVita TMS Therapy System
K150641 · Tonica Elektronik A/S · Jul 2015
Rapid Therapy System
K143531 · Magstim Company Limited · May 2015
NEUROSTAR TMS THERAPY SYSTEM
K133408 · Neuronetics · Mar 2014