# PIB: Diabetic Retinopathy Detection Device

- Device class: 2; regulation: 21 CFR 886.1100; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 199 days (middle half 181–226)
- 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)
- 2018: 1
- 2020: 1
- 2021: 1
- 2022: 2
- 2023: 1
- 2024: 1
- 2026: 1

## Most-cited predicates
- DEN180001: IDx-DR (2018), cited by 3
- K203629: IDx-DR (2021), cited by 2
- K200667: EyeArt (2020), cited by 1
- K221183: Aeye-DS (2022), cited by 1

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