510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212289Substantially Equivalent

NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar

Neuronetics Inc., Malvern PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212289 is the FDA 510(k) clearance record for NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar, a class II device, cleared for Neuronetics, Inc. on under FDA product code QCI (Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder). FDA's definition for product code QCI reads: "External device that uses magnetic fields to induce neural activity in the cerebral cortex to treat neurological and psychiatric disorders and conditions. It is not intended for applying or focusing magnetic fields towards brain areas...". FDA records list 15 510(k) clearances for Neuronetics, Inc., from to . As of , FDA records show no recalls naming K212289.

Clearance record

Decision date
Received
(289 days to decision)
Product code
QCI Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
Regulation
21 CFR 882.5802
Device class
Class II
Review panel
Neurology
Applicant
Neuronetics, Inc. 3222 Phoenixville Pike, Malvern PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QCI

Trailing 12 months

FDA records hold no clearances under product code QCI in the trailing twelve months.

FDA records show no clearances under product code QCI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QCI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260