# DEN070003: Neurostar TMS System

- Pathway: De Novo (Post-NSE)
- Applicant: Neuronetics
- Decided: Oct 7, 2008 after 502 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
No predicates in its family tree.
85 later devices descend from it; 6 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)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K083538: Neurostar TMS Therapy System, Model 1.1 (2008), 84 descendants of its own
- 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

Source page: https://510kreport.com/device/DEN070003
Methodology: https://510kreport.com/methodology