# QEB: Ventilatory Electrical Impedance Tomograph

- Device class: 2; regulation: 21 CFR 868.1505; FDA's rule: 510(k) required
- FDA decisions: 6
- 510(k) review time 2021–2025: median 244 days (middle half 204–265)
- 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)
- 2018: 1
- 2022: 1
- 2023: 2
- 2025: 2

## Most-cited predicates
- K222897: Enlight 2100 (2023), cited by 2
- K211135: Enlight 2100 (2022), cited by 2
- DEN170072: Enlight 1810 (2018), cited by 1

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