# K060168: Vitrification Freeze Kit, Vitrification Thaw Kit

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Scientific Sales Co., Inc.
- Decided: Apr 24, 2006 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
No predicates in its family tree.
30 later devices descend from it; 7 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K080446: Rapidvit and Rapidwarm Cleave (2008), 21 descendants of its own
- K073522: Vitrification Kit & Vitrification Warming Kit (2008), 19 descendants of its own
- K093273: Vit Kit - Freeze and Thaw (2010), 17 descendants of its own
- 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

## Indications for use
Vit Kit - Freeze is intended for ultra-rapid freezing and containment of human blastocysts for Assisted Reproductive Technology (A.R.T.) procedures. This kit is designed for use with Irvine Scientific's Blastocyst Vitrification Thaw Kit (Vit Kit - Thaw, Catalog #90137) for optimal recovery of specimens. Vit Kit - Thaw is intended for the recovery of human blastocysts that have undergone ultra-rapid freezing and containment using Irvine Scientific's Blastocyst Vitrification Freeze Kit (Vit Kit - Freeze, Catalog #90133) for Assisted Reproductive Technology (A.R.T.) procedures.

Source page: https://510kreport.com/device/K060168
Methodology: https://510kreport.com/methodology