# K260248: Ultra-Fast Warm

- Pathway: 510(k) (Traditional)
- Applicant: Kitazato Corporation
- Decided: Apr 28, 2026 after 91 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: 7 generations back to K000309 (2000). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251305: Ultra-Fast Vitri; Ultra-Fast Warm, Kitazato Corporation (2025) Summary page 5.

## Indications for use
Ultra-Fast Warm is indicated for warming of previously vitrified oocytes (MII) and blastocyst stage embryos.

Source page: https://510kreport.com/device/K260248
Methodology: https://510kreport.com/methodology