# K152682: Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit

- Pathway: 510(k) (Special)
- Applicant: Willian A. Cook Australia Pty, Ltd.
- Decided: May 5, 2016 after 230 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 K011157 (2001). 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)
- K011157: Cook Ivf Cryopreservation Kit and the Cook Ivf Thaw Kit, Cook Urological, Inc. (2001) Summary page 5.

## Indications for use
Sydney IVF Cryopreservation Kit is intended for use during in vitro fertilization procedures for cryopreservation of 1-cell to 8-cell embryos. Sydney IVF Thawing Kit is intended for use during in vitro fertilization procedures for thawing of 1-cell to 8-cell embryos.

Source page: https://510kreport.com/device/K152682
Methodology: https://510kreport.com/methodology