# K992954: Keeler Cryo Master & Probes

- Pathway: 510(k) (Traditional)
- Applicant: Keeler Instruments, Inc.
- Decided: Dec 21, 1999 after 111 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
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K062412: Cryomatic (2006), 6 descendants of its own
- K162756: PHAKOS Disposable Retinal Cryo Probe (2017), 2 descendants of its own
- K131787: Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo Probes (2013), 2 descendants of its own
- K180195: Frigitronics adapter (2018), 1 descendant of its own
- K012821: D.O.R.C. Cryostar Cryosurgical System (2001), 1 descendant of its own

## Indications for use
The Keeler CryoMaster & Probes are for use in ophthalmic surgery in cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitrcous cavity, cataract extraction, cryo destruction of lash follicles for trichiasis, and treatment of retinopathy of prematurity (ROP).

Source page: https://510kreport.com/device/K992954
Methodology: https://510kreport.com/methodology