# K160864: Cryotop Vitrification Kit and Cryotop Thawing Kit

- Pathway: 510(k) (Traditional)
- Applicant: Kitazato Biopharma Co., Ltd.
- Decided: Oct 7, 2016 after 192 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: 4 generations back to K000309 (2000). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093273: Vit Kit - Freeze and Thaw, Irvine Scientific Sales Co., Inc. (2010) Summary page 5.

## Most influential descendants
- K180073: Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set (2018), 0 descendants of its own

## Indications for use
The Cryotop® Vitrification Kit is indicated for use in the preparation, vitrification, and storage of pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. The Cryotop® Thawing Kit is indicated for use in the preparation and thawing of vitrified pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

Source page: https://510kreport.com/device/K160864
Methodology: https://510kreport.com/methodology