# K171748: Vitrification Kit and Thawing Kit

- Pathway: 510(k) (Traditional)
- Applicant: Kitazato Corporation
- Decided: Dec 14, 2017 after 184 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.
7 later devices descend from it; 6 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160006: Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit, Irvine Scientific (2016) Summary page 5.

## Most influential descendants
- K251305: Ultra-Fast Vitri; Ultra-Fast Warm (2025), 1 descendant of its own
- K254261: Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK) (2026), 0 descendants of its own
- K260248: Ultra-Fast Warm (2026), 0 descendants of its own
- K242561: Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) (2025), 0 descendants of its own
- K240176: V-VITFREEZE and V-VITWARM (2024), 0 descendants of its own

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

Source page: https://510kreport.com/device/K171748
Methodology: https://510kreport.com/methodology