# OKP: Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache

- Device class: 2; regulation: 21 CFR 882.5808; FDA's rule: 510(k) required
- FDA decisions: 6
- 510(k) review time 2021–2025: median 95 days (middle half 95–95)
- Recalls: 0 (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)
- 2013: 1
- 2014: 1
- 2016: 1
- 2017: 1
- 2019: 1
- 2023: 1

## Most-cited predicates
- K140094: Springtms Total Migraine System (2014), cited by 2
- K162797: SpringTMS (2017), cited by 1
- K182976: SpringTMS (2019), cited by 1
- DEN130022: Neuralieve Cerena Transcranial Magnetic Stimulator (2013), cited by 1

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