# K254261: Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)

- Pathway: 510(k) (Traditional)
- Applicant: Cell Store (Beijing) Biotechnology CO., LTD.
- Decided: Aug 28, 2026 after 241 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)
- K171748: Vitrification Kit and Thawing Kit, Kitazato Corporation (2017) Summary page 5.

## Indications for use
The Vitrification Freeze Kit (Model. CS-IVF-FK) is indicated for use in the vitrification of oocytes (MII), day 3 cleavage stage embryos, and blastocyst stage embryos. The Thawing Kit (Model. CS-IVF-TK) is indicated for use in the thawing of vitrified oocytes (MII), day 3 cleavage stage embryos, and blastocyst stage embryos.

Source page: https://510kreport.com/device/K254261
Methodology: https://510kreport.com/methodology