510(k) · Cleared
ClearedCOOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
William A. Cook Australia Pty., Ltd. · MQL Media, Reproductive
Cleared on Aug 27, 2015 as substantially equivalent to K082363 (William A. Cook Australia Pty., Ltd., 2009) after a 241-day review. Its family tree reaches back 2 generations to 2006. 2 later devices descend from it.
- Decided
- Aug 27, 2015
- Review
- 241 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K060168 (2006). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK060168 Vitrification Freeze Kit, Vitrification Thaw KitIrvine Scientific Sales Co., Inc. · 2006
- 1 generation backK082363 Cook Sydney Ivf Blastocyst Vitrification (K-Sibv-5000), Warming…William A. Cook Australia Pty., Ltd. · 2009
- This deviceK143724 COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF…William A. Cook Australia Pty., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK162409 Gems Vitrification Set, Gems Warming SetGenea Biomedx Pty, Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK161261 Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium…Genea Biomedx Pty, Ltd. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K060168 | Vitrification Freeze Kit, Vitrification Thaw Kit | Irvine Scientific Sales Co., Inc. | 2006 | — |
| −1 | K082363 | Cook Sydney Ivf Blastocyst Vitrification (K-Sibv-5000), Warming (K-Sibw-5000)… | William A. Cook Australia Pty., Ltd. | 2009 | — |
| 0 (this device) | K143724 | COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst… | William A. Cook Australia Pty., Ltd. | 2015 | — |
| +1 | K162409 | Gems Vitrification Set, Gems Warming Set | Genea Biomedx Pty, Ltd. | 2017 | — |
| +1 | K161261 | Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems… | Genea Biomedx Pty, Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MQL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MQL device
- #1 K251305 Ultra-Fast Vitri; Ultra-Fast Warmscore 14.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K082363 | Cook Sydney Ivf Blastocyst Vitrification (K-Sibv-5000), Warming (K-Sibw-5000) KitsSummary page 5…Media, Reproductive PREDICATE DEVICE: COOK Sydney IVF Blastocyst Vitrification Kit & COOK Sydney IVF Blastocyst Warming Kit (product codes: K-SIBV-5000, K-SIBW-5000) (K082363). DEVICE DESCRIPTION: COOK Sydney IVF Blastocyst Vitrification and Warming Kits are intended for the vitrification and warming… | 2009 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 6.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K162409 (Genea Biomedx Pty, Ltd., 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MQL devicesMQL Media, Reproductive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · MQL
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQL
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQL
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQL
3in 2025
MAUDE reports naming product code MQL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 212 | 0 | 0 |
| 2008 | 12 | 151 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 235 | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 5 | 253 | 1 | 1 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 5 | 142 | 0 | 3 |
| 2015 | 7 | 87 | 0 | 0 |
| 2016 | 12 | 170 | 0 | 2 |
| 2017 | 10 | 113 | 0 | 0 |
| 2018 | 4 | 94 | 0 | 0 |
| 2019 | 6 | 170 | 0 | 0 |
| 2020 | 8 | 257 | 1 | 0 |
| 2021 | 1 | — | 2 | 0 |
| 2022 | 3 | 316 | 1 | 0 |
| 2023 | 5 | 199 | 1 | 1 |
| 2024 | 12 | 195 | 0 | 6 |
| 2025 | 9 | 225 | 0 | 3 |
| 2026 | 3 | 179 | 0 | — |
What is it indicated for?
Blastocyst Vitrification Kit is intended for the vitrification of human blastocysts for assisted reproduction technologies (ART). This kit is designed for use with Blastocyst Warming Kit (K-SIBW-5000).
Blastocyst Warming Kit is intended for the warming of human blastocysts that have undergone vitrification using COOK Sydney IVF Vitrification Kit (K-SIBV-5000) for ART procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143724 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143724: COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143724
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026