# K152717: Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit

- Pathway: 510(k) (Special)
- Applicant: William A. Cook Australia Pty., Ltd.
- Decided: May 6, 2016 after 228 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 K030441 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030441: Sydney Ivf Blastocyst Cryopreservation Kit and Sydney Ivf Blastocyst Thaw Kit, Cook Ob/Gyn (2003) Summary page 5.

## Indications for use
Sydney IVF Blastocyst Cryopreservation Kit is intended for use in assisted reproduction technologies for cryopreservation of blastocysts. Sydney IVF Blastocyst Thawing Kit is intended for use in assisted reproduction technologies for thawing of cryopreserved blastocysts.

Source page: https://510kreport.com/device/K152717
Methodology: https://510kreport.com/methodology