# K131787: Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo Probes

- Pathway: 510(k) (Special)
- Applicant: Keeler, Ltd.
- Decided: Dec 23, 2013 after 188 days
- Product code: HRN (Unit, Cryophthalmic, Ac-Powered)
- 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
Longest line of descent: 2 generations back to K874555 (1988). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062412: Cryomatic, Keeler Instruments, Inc. (2006) Summary page 3.
- K112093: Cryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe Adapter, Keeler Instruments, Inc. (2011) Summary page 1.

## Most influential descendants
- K202038: CryoTreQ (2020), 0 descendants of its own
- K160591: D.O.R.C. Disposable Cryo Probe (2017), 0 descendants of its own

## Indications for use
The Keeler Cryomatic System and probes are for use in ophthalmic surgery such as cryopexy for retinal detachment, cyclo destructive procedures Inrefractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, cryo destruction of lash follicles for trichiasis and treatment of retinopathy of prematurity (ROP).

Source page: https://510kreport.com/device/K131787
Methodology: https://510kreport.com/methodology