# QWL: Intraoperative Surgical Angle Measurement Tool

- Device class: 2; regulation: 21 CFR 888.4560; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 30 days (middle half 29–30)
- 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)
- 2023: 1
- 2024: 1
- 2025: 1

## Most-cited predicates
- DEN230012: Ruthless Spine RJB (2023), cited by 1
- K243375: Ruthless Spine RJB (2024), cited by 1
- K252615: Ruthless Spine RJB (2025), cited by 1

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