Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
William A. Cook Australia Pty. , Ltd. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
197 daysmedian FDA review time
257 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K173431 | Towako Transmyometrial Embryo Transfer Set | William A. Cook Australia Pty. , Ltd. | 2018-05-18 | 197 | 0 |
| K171611 | Double Lumen Ovum Aspiration Needles | William A. Cook Australia Pty. , Ltd. | 2017-12-15 | 197 | 0 |
| K160753 | COOK Vacuum Pump | William A. Cook Australia Pty. , Ltd. | 2017-06-13 | 452 | 0 |
| K170257 | Sydney IVF Culture Oil | William A. Cook Australia Pty. , Ltd. | 2017-02-24 | 28 | 0 |
| K153478 | Sydney IVF Gamete Buffer | William A. Cook Australia Pty. , Ltd. | 2016-08-15 | 257 | 0 |
| K152717 | Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blast | William A. Cook Australia Pty. , Ltd. | 2016-05-06 | 228 | 0 |
| K160814 | Sydney IVF Sperm Cryopreservation Buffer | William A. Cook Australia Pty. , Ltd. | 2016-04-22 | 29 | 0 |
| K153290 | Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization M | William A. Cook Australia Pty. , Ltd. | 2016-01-27 | 75 | 0 |
| K151367 | Sydney IVF Hyaluronidase | William A. Cook Australia Pty. , Ltd. | 2016-01-27 | 251 | 0 |
| K152782 | SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDN | William A. Cook Australia Pty. , Ltd. | 2015-12-21 | 87 | 0 |
| K152904 | SYDNEY IVF EMBRYO BIOPSY MEDIUM | William A. Cook Australia Pty. , Ltd. | 2015-12-03 | 63 | 0 |
| K143724 | COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IV | William A. Cook Australia Pty. , Ltd. | 2015-08-27 | 241 | 0 |
| K141365 | OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN | William A. Cook Australia Pty. , Ltd. | 2014-08-07 | 76 | 0 |
| K082363 | COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARM | William A. Cook Australia Pty. , Ltd. | 2009-04-29 | 254 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda