# HRM: Microscope, Operating & Accessories, Ac-Powered, Ophthalmic

- Device class: 1; regulation: 21 CFR 878.4700; FDA's rule: 510(k) exempt
- FDA decisions: 14
- Recalls: 5 (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)
- 1979: 1
- 1982: 1
- 1984: 1
- 1985: 5
- 1989: 2
- 1992: 2
- 1993: 2

## Most-cited predicates

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