510(k) · Cleared
ClearedEmbryoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unisense Fertilitech A/S · MQG Accessory, Assisted Reproduction
Cleared on Aug 11, 2011 as substantially equivalent to K092183 (Unisense Fertilitech A/S, 2011) after a 52-day review. Its family tree reaches back 3 generations to 2004. 9 later devices descend from it.
- Decided
- Aug 11, 2011
- Review
- 52 days
- Class
- Class II
- Product code
- MQG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K040717 (2004). 4 ancestors in all, the oldest K983642 (1999). 9 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK040717 Nunc Ivf Multidish 4 Wells NunclonNunc A/S · 2004
- 2 generations backK070047 Nunc Ivf Dishes and Nunc Ivf 4-Well DishNunc A/S · 2007
- 1 generation backK092183 Embryoscope and EmbryoslideUnisense Fertilitech A/S · 2011
- This deviceK111715 EmbryoscopeUnisense Fertilitech A/S · 2011
- Descendant · cites it directly · 8 of its ownK113075 Embryo Viewer SoftwareUnisense Fertilitech A/S · 2011
- Descendant · 2 generations on · 4 of its ownK133712 Embryoviewer SoftwareUnisense Fertilitech A/S · 2014
- Descendant · 3 generations on · 3 of its ownK173264 EmbryoScope+Vitrolife A/S · 2018
- Descendant · 2 generations on · 2 of its ownK171736 Geri Embryo Incubator and Geri DishGenea Biomedx Pty, Ltd. · 2017
- Descendant · 4 generations on · 0 of its ownK242684 Harioculture TL-16 Time-lapse IncubatorHua Yue Medical Technology Co., Ltd. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K113075Embryo Viewer SoftwareUnisense Fertilitech A/S · 2011 · cites it directly8descendants
- K133712Embryoviewer SoftwareUnisense Fertilitech A/S · 2014 · 2 generations on4descendants
- K173264EmbryoScope+Vitrolife A/S · 2018 · 3 generations on3descendants
- K171736Geri Embryo Incubator and Geri DishGenea Biomedx Pty, Ltd. · 2017 · 2 generations on2descendants
- K242684Harioculture TL-16 Time-lapse IncubatorHua Yue Medical Technology Co., Ltd. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K040717 | Nunc Ivf Multidish 4 Wells Nunclon | Nunc A/S | 2004 | — |
| −2 | K070047 | Nunc Ivf Dishes and Nunc Ivf 4-Well Dish | Nunc A/S | 2007 | — |
| −1 | K092183 | Embryoscope and Embryoslide | Unisense Fertilitech A/S | 2011 | — |
| 0 (this device) | K111715 | Embryoscope | Unisense Fertilitech A/S | 2011 | — |
| +1 | K113075 | Embryo Viewer Software | Unisense Fertilitech A/S | 2011 | — |
| +2 | K133712 | Embryoviewer Software | Unisense Fertilitech A/S | 2014 | — |
| +3 | K173264 | EmbryoScope+ | Vitrolife A/S | 2018 | — |
| +2 | K171736 | Geri Embryo Incubator and Geri Dish | Genea Biomedx Pty, Ltd. | 2017 | — |
| +4 | K242684 | Harioculture TL-16 Time-lapse Incubator | Hua Yue Medical Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K092183 | Embryoscope and EmbryoslideSummary page 1…bmission: Change in Indication for Use to allow device use for up to 5 days (120 hr) of culture. Device design has not been changed from the device cleared under K0921 83. Device name: Trade name Common name Device Class ICFR Reference jProcode -EmbryoSco… | 2011 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113075 | Embryo Viewer Software | 2011 | 8 |
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 7 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K113075 (Unisense Fertilitech A/S, 2011) has gone furthest, with 8 descendants of its own.
- 3 other devices also cite its predicate K092183.
How does its category compare?
All MQG devicesMQG Accessory, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
To provide an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an inverted microscope and imaging system for embryo viewing. Device use is limited to five days (120 hr) covering the time from post-fertilization to day 5 of development.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111715 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111715: Embryoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111715
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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