# HPS: Unit, Cryophthalmic

- Device class: 2; regulation: 21 CFR 886.4170; FDA's rule: 510(k) required
- FDA decisions: 11
- Recalls: 3 (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: 2
- 1980: 1
- 1984: 1
- 1987: 2
- 1988: 1
- 1990: 1
- 1992: 1
- 1994: 1
- 2020: 1

## Most-cited predicates
- K940373: Ophthalmic Cryo Unit (1994), cited by 2
- K874555: Keeler Acu 22XT Ophthalmic Cryo Unit (1988), cited by 1

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