# QSM: System, Surgical, Computer Controlled Instrument, Remanufactured

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 188 days (middle half 182–189)
- 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
- 2024: 1
- 2025: 5
- 2026: 1

## Most-cited predicates

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