# K030441: Sydney Ivf Blastocyst Cryopreservation Kit and Sydney Ivf Blastocyst Thaw Kit

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ob/Gyn
- Decided: Aug 29, 2003 after 199 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K152717: Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit (2016), 0 descendants of its own

## 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/K030441
Methodology: https://510kreport.com/methodology