# QRA: Virtual Reality Behavioral Therapy Device For Pain Relief

- Device class: 2; regulation: 21 CFR 890.5800; FDA's rule: 510(k) required
- FDA decisions: 6
- 510(k) review time 2021–2025: median 137 days (middle half 74–194)
- 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)
- 2021: 1
- 2023: 2
- 2024: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- DEN210014: EaseVRx (2021), cited by 3
- K230814: VRNT (2023), cited by 1
- K243417: RelieVRx (2024), cited by 1

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