# K153478: Sydney IVF Gamete Buffer

- Pathway: 510(k) (Traditional)
- Applicant: William A. Cook Australia Pty., Ltd.
- Decided: Aug 15, 2016 after 257 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: 2 generations back to K022245 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081116: G-Ivf G5 Series, Vitrolife Sweden AB (2008) Summary page 4.

## Indications for use
Sydney IVF Gamete Buffer is used to physically wash and store gametes in preparation for the fertilization step in the IVF process.

Source page: https://510kreport.com/device/K153478
Methodology: https://510kreport.com/methodology