# QNL: Medium-Term Adjunctive Predictive Cardiovascular Indicator

- Device class: 2; regulation: 21 CFR 870.2210; FDA's rule: 510(k) required
- FDA decisions: 6
- 510(k) review time 2021–2025: median 211 days (middle half 107–267)
- 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: 1
- 2023: 2
- 2024: 2
- 2026: 1

## Most-cited predicates
- K200717: CLEWICU System (ClewICUServer and ClewICUnitor) (2021), cited by 4
- K233253: eCARTv5 Clinical Deterioration Suite (“eCART”) (2024), cited by 1
- K231038: Global Hypoperfusion Index (GHI) Algorithm (2023), cited by 1

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