# K223265: CryoX Vitrification Freeze Kit / Thaw Kit

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Horizon Medical Technology Co., Ltd.
- Decided: May 11, 2023 after 199 days
- Product code: MQL (Media, Reproductive)
- Device class: 2
- Regulation: 21 CFR 884.6180
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K000309 (2000). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190152: Vit Kit- Freeze NX and Vit Kit- Warm NX, Fujifilm Irvine Scientific, Inc. (2019) Summary page 4.

## Indications for use
CryoXTM Vitrification Freeze Kit is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. CryoXTM Vitrification Thaw Kit is intended for use in the thawing of vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.

Source page: https://510kreport.com/device/K223265
Methodology: https://510kreport.com/methodology