# HKI: Camera, Ophthalmic, Ac-Powered

- Device class: 2; regulation: 21 CFR 886.1120; FDA's rule: 510(k) required
- FDA decisions: 157
- 510(k) review time 2021–2025: median 158 days (middle half 109–221)
- Recalls: 4 (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)
- 2017: 2
- 2018: 6
- 2019: 4
- 2020: 5
- 2021: 4
- 2022: 1
- 2023: 5
- 2024: 3
- 2025: 4
- 2026: 2

## Most-cited predicates
- K011877: FF450 Plus Fundus Camera and Visupac Digital Image Archiving System, or FF450 Plus Visupac System (2001), cited by 8
- K101935: Centervue Digital Retinography System (2010), cited by 5
- K023719: MP-1 Micro Perimeter (2002), cited by 5
- K041367: Topcon Model TRC-NW200 Non-Mydriatic Retinal Camera (2004), cited by 5
- K980246: Non-Mydriatic Retinal Camera, Model CR6-45NM (1998), cited by 5
- K014274: Non-Mydriatic Fundus Camera, Model NM-1000 (2002), cited by 5
- K180378: Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module (2018), cited by 4
- K091935: Lipiview Ocular Surface Interferometer (2009), cited by 4
- K100207: Non-Mydriatic Retinal Camera, Model TRC-NW8F (2010), cited by 4
- K913929: DFC-1024 & DFC-512 Digital Imaging System (1991), cited by 4

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