# K093273: Vit Kit - Freeze and Thaw

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Scientific Sales Co., Inc.
- Decided: Mar 3, 2010 after 135 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: 3 generations back to K000309 (2000). 7 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080446: Rapidvit and Rapidwarm Cleave, Vitrolife Sweden AB (2008) Summary page 1.
- K060168: Vitrification Freeze Kit, Vitrification Thaw Kit, Irvine Scientific Sales Co., Inc. (2006) Summary page 1.
- K073522: Vitrification Kit & Vitrification Warming Kit, Sage In-Vitro Fertilization, Inc. (2008) Summary page 2.
- K011157: Cook Ivf Cryopreservation Kit and the Cook Ivf Thaw Kit, Cook Urological, Inc. (2001) Summary page 5.

## Most influential descendants
- K160006: Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit (2016), 14 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K093273
Methodology: https://510kreport.com/methodology