# HMX: Cannula, Ophthalmic

- Device class: 1; regulation: 21 CFR 886.4350; FDA's rule: 510(k) exempt
- FDA decisions: 77
- Recalls: 20 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1988: 33
- 1989: 1
- 1990: 1
- 1991: 1
- 1992: 2
- 1994: 3
- 1995: 1
- 1997: 1
- 2000: 1
- 2001: 1

## Most-cited predicates
- K010305: Weiss Retinal Cannula (2001), cited by 1
- K874985: Prisma Disposable Capsule Polisher (1988), cited by 1
- K874973: Prisma Disposable Simcoe I/a Cannula (1988), cited by 1
- K874969: Prisma Disposable Kratz Capsule Polisher (1988), cited by 1
- K874974: Prisma Disposable Simcoe Capsule Polisher (1988), cited by 1
- K921488: Aspirating Endo Ocular Probe W/Illumination (1992), cited by 1

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