# K160006: Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Scientific
- Decided: May 4, 2016 after 121 days
- Product code: MQL (Media, Reproductive)
- Device class: 2
- Regulation: 21 CFR 884.6180
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K000309 (2000). 8 ancestors in all.
14 later devices descend from it; 4 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093273: Vit Kit - Freeze and Thaw, Irvine Scientific Sales Co., Inc. (2010) Summary page 5.

## Most influential descendants
- K171748: Vitrification Kit and Thawing Kit (2017), 7 descendants of its own
- K190152: Vit Kit- Freeze NX and Vit Kit- Warm NX (2019), 2 descendants of its own
- K251305: Ultra-Fast Vitri; Ultra-Fast Warm (2025), 1 descendant of its own
- K173731: SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) (2018), 1 descendant of its own
- K254261: Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK) (2026), 0 descendants of its own

## Recalls of this device
- Sep 8, 2021 · Class II · Z-0248-2022: Due to a component in kit being labeled with the incorrect Expiration Date
- Sep 8, 2021 · Class II · Z-0249-2022: Due to a component in kit being labeled with the incorrect Expiration Date

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

Source page: https://510kreport.com/device/K160006
Methodology: https://510kreport.com/methodology