# QJF: Autofluorescence Imaging Adjunct Tool For Wounds

- Device class: 2; regulation: 21 CFR 878.4550; FDA's rule: 510(k) required
- FDA decisions: 7
- 510(k) review time 2021–2025: median 160 days (middle half 89–202)
- Recalls: 1 (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
- 2021: 2
- 2022: 1
- 2023: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K191371: MolecuLight i:X (2019), cited by 4
- K211901: MolecuLightDX (2021), cited by 1
- K210882: MolecuLight I:X (2021), cited by 1

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