# K083538: Neurostar TMS Therapy System, Model 1.1

- Pathway: 510(k) (Special)
- Applicant: Neuronetics
- Decided: Dec 16, 2008 after 18 days
- Product code: OBP (Transcranial Magnetic Stimulator)
- Device class: 2
- Regulation: 21 CFR 882.5805
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN070003 (2008). 1 ancestor in all.
84 later devices descend from it; 9 cite it directly.
0 of 86 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.

## Most influential descendants
- K130233: Neurostar TMS Therapy System (2013), 78 descendants of its own
- K133408: Neurostar TMS Therapy System (2014), 77 descendants of its own
- 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

## Recalls of this device
- Mar 16, 2009 · Not classified · Z-1421-2009: SenStar Treatment Link may have an open circuit that during use with the NeuroStar TMS Therapy system may cause arcing and heat damage to the SenStar and/or treatment coil. Heating of the SenStar duri

## Indications for use
The NeuroStar TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode.

Source page: https://510kreport.com/device/K083538
Methodology: https://510kreport.com/methodology