# QRG: Ultrasound Guided Nerve Block Assist

- Device class: 2; regulation: 21 CFR 868.1980; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 88 days (middle half 56–119)
- 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)
- 2022: 1
- 2023: 1
- 2025: 1

## Most-cited predicates
- K232787: ScanNav Anatomy Peripheral Nerve Block (2023), cited by 1
- DEN220024: ScanNav Anatomy Peripheral Nerve Block (2022), cited by 1

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