# K180073: Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Vitavitro Bio-Tech Co., Ltd.
- Decided: Aug 29, 2018 after 232 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: 5 generations back to K000309 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160864: Cryotop Vitrification Kit and Cryotop Thawing Kit, Kitazato Biopharma Co., Ltd. (2016) Summary page 4.

## Indications for use
VitaVitro Vitrification Kit is intended for the vitrification of human blastocysts for assisted reproduction technologies (ART). This kit is designed for use with VitaVitro Warming Kit. VitaVitro Warming Kit is intended for the warming of human blastocysts that have undergone vitrification using VitaVitro Vitrification Kit for ART procedures. VitaVitro Straw Set is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human blastocyst stage embryos.

Source page: https://510kreport.com/device/K180073
Methodology: https://510kreport.com/methodology