# K133408: Neurostar TMS Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Neuronetics
- Decided: Mar 28, 2014 after 142 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: 3 generations back to DEN070003 (2008). 3 ancestors in all.
77 later devices descend from it; 9 cite it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K083538: Neurostar TMS Therapy System, Model 1.1, Neuronetics (2008) Summary page 1.
- K130233: Neurostar TMS Therapy System, Neuronetics (2013) Summary page 1.

## Most influential descendants
- K143531: Rapid Therapy System (2015), 62 descendants of its own
- K150641: MagVita TMS Therapy System (2015), 57 descendants of its own
- K160703: NeuroStar TMS Therapy System (2016), 55 descendants of its own
- K171481: MagVita TMS Therapy System (2017), 48 descendants of its own
- K160309: Neurosoft TMS (2016), 46 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/K133408
Methodology: https://510kreport.com/methodology