# OBP: Transcranial Magnetic Stimulator

- Device class: 2; regulation: 21 CFR 882.5805; FDA's rule: 510(k) required
- FDA decisions: 69
- 510(k) review time 2021–2025: median 132 days (middle half 90–191)
- Recalls: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 8
- 2018: 4
- 2019: 3
- 2020: 1
- 2021: 5
- 2022: 6
- 2023: 7
- 2024: 5
- 2025: 12
- 2026: 8

## Most-cited predicates
- K150641: MagVita TMS Therapy System (2015), cited by 11
- K083538: Neurostar TMS Therapy System, Model 1.1 (2008), cited by 9
- K133408: Neurostar TMS Therapy System (2014), cited by 9
- K173620: Mag Vita TMS Therapy System w/Theta Burst Stimulation (2018), cited by 9
- K160703: NeuroStar TMS Therapy System (2016), cited by 8
- K171481: MagVita TMS Therapy System (2017), cited by 7
- K161519: NeuroStar TMS Therapy System (2016), cited by 7
- K143531: Rapid Therapy System (2015), cited by 7
- K130233: Neurostar TMS Therapy System (2013), cited by 6
- DEN070003: Neurostar TMS System (2008), cited by 6

Source page: https://510kreport.com/product-code/OBP
Data by year (CSV): https://510kreport.com/product-code/OBP.csv