# QIS: Esophageal, Mucosal, Electrical Characterization

- Device class: 2; regulation: 21 CFR 876.1450; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 186 days (middle half 146–226)
- 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)
- 2019: 1
- 2023: 1
- 2024: 1

## Most-cited predicates
- DEN180067: Mucosal Integrity Conductivity (MI) Test System (2019), cited by 2

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