# QSN: Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System

- Device class: 2; regulation: 21 CFR 866.3988; FDA's rule: 510(k) required
- FDA decisions: 1
- Recalls: 2 (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

## Most-cited predicates

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