# HPX: Lens, Contact (Polymethylmethacrylate)

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 74
- 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)
- 1986: 27
- 1987: 23
- 1988: 50
- 1989: 11
- 1990: 24
- 1991: 11
- 1992: 7
- 1993: 5
- 1994: 4
- 1996: 1

## Most-cited predicates
- K852384: Sight Saver All Purpose Lens Carrying Case (1985), cited by 2
- P840004/S007: Saturn II (TM) (Synergicon a) Contact Lens (1993), cited by 2

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