510(k) · Cleared
ClearedGeri Embryo Incubator and Geri Dish
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genea Biomedx Pty, Ltd. · MQG Accessory, Assisted Reproduction
Cleared on Apr 20, 2018 as substantially equivalent to K171736 (Genea Biomedx Pty, Ltd., 2017) after a 77-day review. Its family tree reaches back 6 generations to 2004.
- Decided
- Apr 20, 2018
- Review
- 77 days
- Class
- Class II
- Product code
- MQG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K040717 (2004). 7 ancestors in all, the oldest K983642 (1999). No later device cites it as a predicate yet.
- Root · 6 generations backK040717 Nunc Ivf Multidish 4 Wells NunclonNunc A/S · 2004
- 5 generations backK070047 Nunc Ivf Dishes and Nunc Ivf 4-Well DishNunc A/S · 2007
- 4 generations backK092183 Embryoscope and EmbryoslideUnisense Fertilitech A/S · 2011
- 3 generations backK111715 EmbryoscopeUnisense Fertilitech A/S · 2011
- 2 generations backK113075 Embryo Viewer SoftwareUnisense Fertilitech A/S · 2011
- 1 generation backK171736 Geri Embryo Incubator and Geri DishGenea Biomedx Pty, Ltd. · 2017
- This deviceK180304 Geri Embryo Incubator and Geri DishGenea Biomedx Pty, Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K040717 | Nunc Ivf Multidish 4 Wells Nunclon | Nunc A/S | 2004 | — |
| −5 | K070047 | Nunc Ivf Dishes and Nunc Ivf 4-Well Dish | Nunc A/S | 2007 | — |
| −4 | K092183 | Embryoscope and Embryoslide | Unisense Fertilitech A/S | 2011 | — |
| −3 | K111715 | Embryoscope | Unisense Fertilitech A/S | 2011 | — |
| −2 | K113075 | Embryo Viewer Software | Unisense Fertilitech A/S | 2011 | — |
| −1 | K171736 | Geri Embryo Incubator and Geri Dish | Genea Biomedx Pty, Ltd. | 2017 | — |
| 0 (this device) | K180304 | Geri Embryo Incubator and Geri Dish | Genea Biomedx Pty, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 MQG? 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 MQG device
- #1 K261083 Wallace® Aspiration Pump (WAPV1); Wallace®…score 12.2 · 2 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 |
|---|---|---|---|
| * | K171736 | Geri Embryo Incubator and Geri DishSummary page 4…pe and Microscope Accessories, Reproduction, Assisted) Regulatory Class: II IV. Predicate Device Geri Embryo Incubator (K171736) manufactured by Genea Biomedx, Australia. The predicate device has not been subject to any design related recalls. V. Device De… | 2017 |
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 14 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 1 other device also cites its predicate K171736.
How does its category compare?
All MQG devicesMQG Accessory, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MQG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQG
135in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQG
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQG
1in 2025
MAUDE reports naming product code MQG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 4 | 137 | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 3 | 236 | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 3 | 135 | 0 | 0 |
| 2019 | 0 | — | 1 | 2 |
| 2020 | 0 | — | 1 | 3 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 3 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Geri Embryo Incubator is intended to provide an environment with controlled temperature and mixed gas (CO2 and other gases) for the development of embryos. The Geri Embryo Incubator has an integrated camera and optics for imaging and viewing embryos during incubation, for a maximum time of 120 hours.
The Geri Dish is intended to be used for preparation, storage and imaging of human embryos. The Geri Dish is intended to be used only with the Geri Embryo Incubator.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180304 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180304: Geri Embryo Incubator and Geri Dish.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180304
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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