# HOX: Chart, Visual Acuity

- Device class: 1; regulation: 21 CFR 886.1150; FDA's rule: 510(k) exempt
- FDA decisions: 32
- 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)
- 1981: 1
- 1982: 3
- 1983: 1
- 1984: 4
- 1985: 3
- 1986: 3
- 1987: 2
- 1988: 11
- 1995: 1
- 2010: 1

## Most-cited predicates
- K100095: Central Vision Analyzer Model 1000 (2010), cited by 1

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