# K161519: NeuroStar TMS Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Neuronetics, Inc.
- Decided: Sep 11, 2016 after 101 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: 5 generations back to DEN070003 (2008). 5 ancestors in all.
27 later devices descend from it; 7 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133408: Neurostar TMS Therapy System, Neuronetics (2014) Summary page 4.
- K160703: NeuroStar TMS Therapy System, Neuronetics, Inc. (2016). Cleared while this submission was under review Summary page 5.

## Most influential descendants
- K201158: NeuroStar Advanced Therapy (2020), 24 descendants of its own
- K212289: NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar (2022), 19 descendants of its own
- K220127: NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health (2022), 16 descendants of its own
- 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

## Indications for use
The NeuroStar TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

Source page: https://510kreport.com/device/K161519
Methodology: https://510kreport.com/methodology