510(k) · Cleared
ClearedGems Vitrification Set, Gems Warming Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genea Biomedx Pty, Ltd. · MQL Media, Reproductive
Cleared on May 24, 2017 as substantially equivalent to K143724 (William A. Cook Australia Pty., Ltd., 2015) after a 268-day review. Its family tree reaches back 3 generations to 2006.
- Decided
- May 24, 2017
- Review
- 268 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K060168 (2006). No later device cites it as a predicate yet.
- Root · 3 generations backK060168 Vitrification Freeze Kit, Vitrification Thaw KitIrvine Scientific Sales Co., Inc. · 2006
- 2 generations backK082363 Cook Sydney Ivf Blastocyst Vitrification (K-Sibv-5000), Warming…William A. Cook Australia Pty., Ltd. · 2009
- 1 generation backK143724 COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF…William A. Cook Australia Pty., Ltd. · 2015
- This deviceK162409 Gems Vitrification Set, Gems Warming SetGenea Biomedx Pty, Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K060168 | Vitrification Freeze Kit, Vitrification Thaw Kit | Irvine Scientific Sales Co., Inc. | 2006 | — |
| −2 | K082363 | Cook Sydney Ivf Blastocyst Vitrification (K-Sibv-5000), Warming (K-Sibw-5000)… | William A. Cook Australia Pty., Ltd. | 2009 | — |
| −1 | K143724 | COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst… | William A. Cook Australia Pty., Ltd. | 2015 | — |
| 0 (this device) | K162409 | Gems Vitrification Set, Gems Warming Set | Genea Biomedx Pty, Ltd. | 2017 | — |
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 |
|---|---|---|---|
| * | K143724 | COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming KitSummary page 4…Media, Reproductive) Regulatory Class: II IV. Predicate Devices Cook Sydney IVF Blastocyst Vitrification Kit and Cook Sydney IVF Blastocyst Warming Kit (K143724) These predicate devices have not been subject to any design-related recalls. V. Indications for Use Gems Vitrification Set is… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K143724.
How does its category compare?
All MQL devicesMQL Media, Reproductive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Gems Vitrification Set is used for the vitrification of human blastocyst stage embryos for Assisted Reproductive Technology (ART) procedures.
Gems Warming Set is used for the warming of human blastocyst stage embryos that have undergone vitrification.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162409 · printed Nov 4, 2026
Cite this page
510(k) Report. “K162409: Gems Vitrification Set, Gems Warming Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K162409
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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