# K190152: Vit Kit- Freeze NX and Vit Kit- Warm NX

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Irvine Scientific, Inc.
- Decided: Jun 21, 2019 after 142 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.
2 later devices descend from it; 2 cite 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)
- 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 4.

## Most influential descendants
- K250445: Fast Warm - NX (2025), 0 descendants of its own
- K223265: CryoX Vitrification Freeze Kit / Thaw Kit (2023), 0 descendants of its own

## Indications for use
Vit Kit - Freeze NX (Vitrification Freeze Kit) is intended for use in the vitrification of oocytes (MII) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. Vit Kit - Warm NX (Vitrification Warm Kit) is intended for use in the thawing of vitrified oocytes (MII) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

Source page: https://510kreport.com/device/K190152
Methodology: https://510kreport.com/methodology