510(k) · Cleared
ClearedGems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase
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 12, 2017 as substantially equivalent to K153290 (William A. Cook Australia Pty., Ltd., 2016) and 2 other predicates after a 373-day review. Its family tree reaches back 4 generations to 2004.
- Decided
- May 12, 2017
- Review
- 373 days
- Class
- Class II
- Product code
- MQL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K034063 (2004). 10 ancestors in all, the oldest K002385 (2000). No later device cites it as a predicate yet.
- Root · 4 generations backK034063 Multiblast MediumIrvine Scientific Sales Co., Inc. · 2004
- 3 generations backK072609 Single Step MediumIrvine Scientific Sales Co., Inc. · 2008
- 2 generations backK121572 Continuous Single Culture CompleteIrvine Scientific Sales Co., Inc. · 2012
- 1 generation backK133568 G-TLVitrolife, Inc. · 2014
- This deviceK161261 Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium…Genea Biomedx Pty, Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K034063 | Multiblast Medium | Irvine Scientific Sales Co., Inc. | 2004 | — |
| −3 | K072609 | Single Step Medium | Irvine Scientific Sales Co., Inc. | 2008 | — |
| −2 | K121572 | Continuous Single Culture Complete | Irvine Scientific Sales Co., Inc. | 2012 | — |
| −1 | K133568 | G-TL | Vitrolife, Inc. | 2014 | — |
| 0 (this device) | K161261 | Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems… | Genea Biomedx Pty, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K153290 | Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage…Summary page 4…Regulatory Class: II IV. Predicate Devices 1. Sydney IVF Fertilization Medium, Sydney IFV Cleavage Medium and Sydney IVF Blastocyst Medium (K153290), manufactured by William A. Cook Australia Pty Ltd 2. G-Tl (K133568), manufactured by Vitrolife, Inc. 3. Cook Sydney I… | 2016 |
| * | K133568 | G-TLSummary page 4…IVF Fertilization Medium, Sydney IFV Cleavage Medium and Sydney IVF Blastocyst Medium (K153290), manufactured by William A. Cook Australia Pty Ltd 2. G-Tl (K133568), manufactured by Vitrolife, Inc. 3. Cook Sydney IVF Blastocyst Vitrification Kit, Cook Sydney IVF Blastocyst Warming Kit (K… | 2014 |
| * | K143724 | COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming KitSummary page 4…k Australia Pty Ltd 2. G-Tl (K133568), manufactured by Vitrolife, Inc. 3. Cook Sydney IVF Blastocyst Vitrification Kit, Cook Sydney IVF Blastocyst Warming Kit (K143724), manufactured by William A. Cook Australia Pty Ltd These predicate devices have not been subject to any design related… | 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 13 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- None of the 10 ancestors has a recall.
- 4 other devices also cite its predicate K153290.
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 Fertilisation Medium is used to provide a suitable environment for both oocytes and sperm and support in vitro fertilisation. This medium can be used for transfer of zygotes into the uterus. Gems Cleavage Medium is for in vitro culture of embryos following fertilization to the 4-8 cell stage. This medium can be used for transfer of cleavage stage embryos into the uterus. Gems Blastocyst Medium is for in vitro culture of embryos from the cleavage…
Read the full statement (164 words)
Gems Fertilisation Medium is used to provide a suitable environment for both oocytes and sperm and support in vitro fertilisation. This medium can be used for transfer of zygotes into the uterus.
Gems Cleavage Medium is for in vitro culture of embryos following fertilization to the 4-8 cell stage. This medium can be used for transfer of cleavage stage embryos into the uterus.
Gems Blastocyst Medium is for in vitro culture of embryos from the cleavage stage to the blastocyst stage of development. This medium can be used for transfer of blastocyst stage embryos into the uterus.
Gems Geri Medium is for in vitro culture of embryos from fertilization to the blastocyst stage of development. This medium can be used for transfer of embryos into the uterus.
Gems VitBase is used to maintain embryos for a short period of time in a non-gassed environment during embryo vitrification and warming procedures. The embryos can be placed in this medium for a maximum of 10 minutes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161261 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161261: Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161261
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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