# PKR: Non-Invasive Vagus Nerve Stimulator - Headache

- Device class: 2; regulation: 21 CFR 882.5892; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 78 days (middle half 74–82)
- 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)
- 2017: 3
- 2018: 3
- 2020: 1
- 2021: 2

## Most-cited predicates
- K171306: gammaCore-S (2017), cited by 2
- K180538: gammaCore Sapphire (2018), cited by 1
- DEN150048: gammaCore Non-invasive Vagus Nerve Stimulator (2017), cited by 1
- K182369: gammaCore Sapphire (2018), cited by 1
- K172270: gammaCore-2 (2017), cited by 1
- K191830: gammaCore Sapphire (2020), cited by 1
- K203546: gammaCore Sapphire (2021), cited by 1

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