# K082363: Cook Sydney Ivf Blastocyst Vitrification (K-Sibv-5000), Warming (K-Sibw-5000) Kits

- Pathway: 510(k) (Traditional)
- Applicant: William A. Cook Australia Pty., Ltd.
- Decided: Apr 29, 2009 after 254 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: 1 generation back to K060168 (2006). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060168: Vitrification Freeze Kit, Vitrification Thaw Kit, Irvine Scientific Sales Co., Inc. (2006) Summary page 2.

## Most influential descendants
- K143724: COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit (2015), 2 descendants of its own
- K162409: Gems Vitrification Set, Gems Warming Set (2017), 0 descendants of its own
- K161261: Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase (2017), 0 descendants of its own

## Indications for use
Blastocyst Warming Kit is intended for the recovery of human blastocysts that have undergone vitrification using COOK Sydney IVF Blastocyst Vitrification Kit (K-SIBV-5000) for ART procedures. Blastocyst Vitrification Kit is intended for the vitrification of human blastocysts for assisted reproduction procedures (ART). This kit is designed for use with Blastocyst Warming Kit (K-SIBW-5000)

Source page: https://510kreport.com/device/K082363
Methodology: https://510kreport.com/methodology