# K251305: Ultra-Fast Vitri; Ultra-Fast Warm

- Pathway: 510(k) (Traditional)
- Applicant: Kitazato Corporation
- Decided: Aug 26, 2025 after 120 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.
1 later device descends from it; 1 cites it directly.
0 of 12 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.

## Most influential descendants
- K260248: Ultra-Fast Warm (2026), 0 descendants of its own

## Indications for use
Ultra-Fast Vitri is indicated for use in the preparation, vitrification and storage of oocytes (MII). Ultra-Fast Warm is indicated for use in the preparation and warming of vitrified oocytes(MII).

Source page: https://510kreport.com/device/K251305
Methodology: https://510kreport.com/methodology