Cleared Traditional

NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health (K220127) - FDA 510(k) Clearance

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

K220127 · Neuronetics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
178d
Days
Class 2
Risk

K220127 is an FDA 510(k) clearance for the NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, N.... 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 July 15, 2022 after a review of 178 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 K220127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2022
Decision Date July 15, 2022
Days to Decision 178 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
30d slower than avg
Panel avg: 148d · This submission: 178d
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 K220127.
Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K
K220177 · Magnus Medical, Inc. · Sep 2022
BrainsWay Deep TMS System
K220819 · Brainsway , Ltd. · Aug 2022
NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health
K222230 · Neuronetics, Inc. · Aug 2022
ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System
K220625 · Remed Co., Ltd. · Apr 2022
BTL-995-rTMS
K212723 · BTL Industries, Inc. · Mar 2022
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
K213543 · Neuronetics, Inc. · Dec 2021