# William A. Cook Australia Pty., Ltd.

- Location (FDA's records): Eight Mile Plains, AU
- FDA decisions: 14 (2009–2018): 14 510(k) clearances
- Product codes: MQL (10), MQE (2), MQG (1), MQF (1)
- 510(k) review time since 2016: median 197 days, against 170 for FDA's reviews in the same codes and years (4 of 8 faster)
- Predicates its devices cite: 14 (1 its own); citations of its devices by later devices: 11 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cook Ob/Gyn: 7 (https://510kreport.com/company/cook-ob-gyn)
- Cook Urological, Inc.: 4 (https://510kreport.com/company/cook-urological)
- Irvine Scientific Sales Co., Inc.: 1 (https://510kreport.com/company/irvine-scientific-sales)
- Vitrolife Sweden AB: 1 (https://510kreport.com/company/vitrolife-sweden)

## Firms that cite its devices most
- Genea Biomedx Pty, Ltd.: 3 (https://510kreport.com/company/genea-biomedx)
- Kitazato Corporation: 2 (https://510kreport.com/company/kitazato)
- Donnevie Medical Technology (Shanghai) Co., Ltd.: 2 (https://510kreport.com/company/donnevie-medical-technology-shanghai)
- Shenzhen Vitavitro Biotech Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-vitavitro-biotech)
- CooperSurgical, Inc.: 1 (https://510kreport.com/company/coopersurgical)
- Sheng Sheng Yi (Beijing) Technology Company Limited: 1 (https://510kreport.com/company/sheng-sheng-yi-beijing-technology)

## Its most-cited devices
- K153290: Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium (2016), cited by 5
- K160753: COOK Vacuum Pump (2017), cited by 2
- K143724: COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit (2015), cited by 2
- K082363: Cook Sydney Ivf Blastocyst Vitrification (K-Sibv-5000), Warming (K-Sibw-5000) Kits (2009), cited by 1
- K152782: Sydney Ivf Sperm Medium, Sydney Ivf Sperm Gradient Kit, Sydney Ivf Spermient (2015), cited by 1

## Recent decisions
- K173431: Towako Transmyometrial Embryo Transfer Set (May 18, 2018)
- K171611: Double Lumen Ovum Aspiration Needles (Dec 15, 2017)
- K160753: COOK Vacuum Pump (Jun 13, 2017)
- K170257: Sydney IVF Culture Oil (Feb 24, 2017)
- K153478: Sydney IVF Gamete Buffer (Aug 15, 2016)
- K152717: Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit (May 6, 2016)
- K160814: Sydney IVF Sperm Cryopreservation Buffer (Apr 22, 2016)
- K151367: Sydney IVF Hyaluronidase (Jan 27, 2016)

Source page: https://510kreport.com/company/william-a-cook-australia