# K250445: Fast Warm - NX

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Irvine Scientific
- Decided: Sep 12, 2025 after 210 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.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190152: Vit Kit- Freeze NX and Vit Kit- Warm NX, Fujifilm Irvine Scientific, Inc. (2019) Summary page 5.

## Indications for use
Fast Warm - NX is intended for use in assisted reproductive procedures for the thawing of vitrified human blastocyst stage embryos.

Source page: https://510kreport.com/device/K250445
Methodology: https://510kreport.com/methodology