# K220127: NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health

- Pathway: 510(k) (Traditional)
- Applicant: Neuronetics, Inc.
- Decided: Jul 15, 2022 after 178 days
- Product code: OBP (Transcranial Magnetic Stimulator)
- Device class: 2
- Regulation: 21 CFR 882.5805
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to DEN070003 (2008). 10 ancestors in all.
16 later devices descend from it; 5 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210201: Deep Transcranial Magnetic Stimulation (DTMS) System, Brainsway, Ltd. (2021) Summary page 4.
- K201158: NeuroStar Advanced Therapy, Neuronetics, Inc. (2020) Summary page 4.
- K161519: NeuroStar TMS Therapy System, Neuronetics, Inc. (2016) Summary page 4.
- K160703: NeuroStar TMS Therapy System, Neuronetics, Inc. (2016) Summary page 4.
- K133408: Neurostar TMS Therapy System, Neuronetics (2014) Summary page 4.
- K130233: Neurostar TMS Therapy System, Neuronetics (2013) Summary page 4.
- K083538: Neurostar TMS Therapy System, Model 1.1, Neuronetics (2008) Summary page 4.
- DEN070003: Neurostar TMS System, Neuronetics (2008). Our reading of the summary gave K061053, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN070003, Neurostar TMS System (Neuronetics), granted Oct 7, 2008; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Cited in the summary but kept off the family tree
- DEN060153: NeuroStar Advanced Therapy System. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 6.

## Most influential descendants
- K230029: NeuroStar Advanced Therapy System (Version 3.7) (2023), 13 descendants of its own
- K231926: NeuroStar Advanced Therapy System (All previously cleared models) (2024), 7 descendants of its own
- K251119: MagVenture TMS Therapy System (2025), 3 descendants of its own
- K243700: Apollo TMS Therapy System (2025), 1 descendant of its own
- K251125: MagVenture TMS Therapy System (2025), 1 descendant of its own

## Indications for use
The NeuroStar Advanced Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.

Source page: https://510kreport.com/device/K220127
Methodology: https://510kreport.com/methodology