# K202038: CryoTreQ

- Pathway: 510(k) (Traditional)
- Applicant: VitreQ BV
- Decided: Dec 30, 2020 after 160 days
- Product code: HPS (Unit, Cryophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4170
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K874555 (1988). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940373: Ophthalmic Cryo Unit, Dutch Ophthalmic USA, Inc. (1994) Summary page 4.
- K131787: Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo Probes, Keeler, Ltd. (2013) Summary page 4.

## Recalls of this device
- Mar 17, 2023 · Class II · Z-1497-2023: Device suddenly and forcefully disassembled after cryotherapy, potential for long-term or permanent impairment of a patient or user if a CryoTreq device suddenly or forcefully disassembles during a cr

## Indications for use
The VitreQ CryoTreQ is indicated for use in ophthalmic surgery such as cryopexy for retinal detachment, cyclodestructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, cryodestruction of lash follicles for trichiasis and the treatment of retinopathy of prematurity (ROP).

Source page: https://510kreport.com/device/K202038
Methodology: https://510kreport.com/methodology