# QNV: Adjunctive Hemodynamic Indicator With Decision Point

- Device class: 2; regulation: 21 CFR 870.2220; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 110 days (middle half 94–125)
- 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)
- 2021: 2
- 2022: 1

## Most-cited predicates
- DEN200022: Analytic for Hemodynamic Instability (AHI) (2021), cited by 2
- K212219: AHI System (2021), cited by 1

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