# K940373: Ophthalmic Cryo Unit

- Pathway: 510(k) (Traditional)
- Applicant: Dutch Ophthalmic USA, Inc.
- Decided: Jul 18, 1994 after 173 days
- Product code: HPS (Unit, Cryophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012821: D.O.R.C. Cryostar Cryosurgical System (2001), 1 descendant of its own
- K202038: CryoTreQ (2020), 0 descendants of its own
- K160591: D.O.R.C. Disposable Cryo Probe (2017), 0 descendants of its own

Source page: https://510kreport.com/device/K940373
Methodology: https://510kreport.com/methodology