# HRN: Unit, Cryophthalmic, Ac-Powered

- Device class: 2; regulation: 21 CFR 886.4170; FDA's rule: 510(k) required
- FDA decisions: 10
- 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)
- 1983: 1
- 1999: 1
- 2001: 1
- 2006: 1
- 2011: 1
- 2013: 1
- 2017: 2
- 2018: 1
- 2020: 1

## Most-cited predicates
- K112093: Cryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe Adapter (2011), cited by 2
- K162756: PHAKOS Disposable Retinal Cryo Probe (2017), cited by 2
- K062412: Cryomatic (2006), cited by 2
- K992954: Keeler Cryo Master & Probes (1999), cited by 2
- K131787: Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo Probes (2013), cited by 2
- K012821: D.O.R.C. Cryostar Cryosurgical System (2001), cited by 1
- K180195: Frigitronics adapter (2018), cited by 1

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