510(k) · Cleared
ClearedEmbryoviewer Software
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 8, 2014 as substantially equivalent to K113075 (Unisense Fertilitech A/S, 2011) after a 246-day review. Its family tree reaches back 5 generations to 2004. 4 later devices descend from it.
- Decided
- Aug 8, 2014
- Review
- 246 days
- Class
- Class II
- Product code
- MQG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K040717 (2004). 6 ancestors in all, the oldest K983642 (1999). 4 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK040717 Nunc Ivf Multidish 4 Wells NunclonNunc A/S · 2004
- 4 generations backK070047 Nunc Ivf Dishes and Nunc Ivf 4-Well DishNunc A/S · 2007
- 3 generations backK092183 Embryoscope and EmbryoslideUnisense Fertilitech A/S · 2011
- 2 generations backK111715 EmbryoscopeUnisense Fertilitech A/S · 2011
- 1 generation backK113075 Embryo Viewer SoftwareUnisense Fertilitech A/S · 2011
- This deviceK133712 Embryoviewer SoftwareUnisense Fertilitech A/S · 2014
- Descendant · cites it directly · 3 of its ownK173264 EmbryoScope+Vitrolife A/S · 2018
- Descendant · 2 generations on · 0 of its ownK242684 Harioculture TL-16 Time-lapse IncubatorHua Yue Medical Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK232493 Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish…Wuhan Huchuang Union Technology Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK213869 EmbryoSlide+ ic8 dishVitrolife A/S · 2022
Most influential descendants
Showing 4 of 4 · See all- K173264EmbryoScope+Vitrolife A/S · 2018 · cites it directly3descendants
- K242684Harioculture TL-16 Time-lapse IncubatorHua Yue Medical Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K232493Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)Wuhan Huchuang Union Technology Co., Ltd. · 2024 · 2 generations on0descendants
- K213869EmbryoSlide+ ic8 dishVitrolife A/S · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K040717 | Nunc Ivf Multidish 4 Wells Nunclon | Nunc A/S | 2004 | — |
| −4 | K070047 | Nunc Ivf Dishes and Nunc Ivf 4-Well Dish | Nunc A/S | 2007 | — |
| −3 | K092183 | Embryoscope and Embryoslide | Unisense Fertilitech A/S | 2011 | — |
| −2 | K111715 | Embryoscope | Unisense Fertilitech A/S | 2011 | — |
| −1 | K113075 | Embryo Viewer Software | Unisense Fertilitech A/S | 2011 | — |
| 0 (this device) | K133712 | Embryoviewer Software | Unisense Fertilitech A/S | 2014 | — |
| +1 | K173264 | EmbryoScope+ | Vitrolife A/S | 2018 | — |
| +2 | K242684 | Harioculture TL-16 Time-lapse Incubator | Hua Yue Medical Technology Co., Ltd. | 2025 | — |
| +2 | K232493 | Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) | Wuhan Huchuang Union Technology Co., Ltd. | 2024 | — |
| +2 | K213869 | EmbryoSlide+ ic8 dish | Vitrolife A/S | 2022 | — |
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 |
|---|---|---|
| 2018 | 1 | 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 |
|---|---|---|---|
| * | K113075 | Embryo Viewer SoftwareSummary page 2…shes with 12 embryos in each culture dish) can be incubated simultaneously. Indications for use EmbryoScope® time-lapse incubator (Version D) EmbryoScope EmbryoScope (K113075) Indications for use The EmbryoScope® time- lapse incubator (Version D) provides an environment with controlled temperature, CO… | 2011 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173264 | EmbryoScope+ | 2018 | 3 |
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 10 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K173264 (Vitrolife A/S, 2018) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K113075.
How does its category compare?
All MQG devicesMQG Accessory, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 EmbryoScope® time-lapse incubator (version D) provides an environment with controlled temperature, CO2 (and other gasses) for the development of embryos. This model has an integrated 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. The EmbryoViewer™ software is an optional accessory software package for use in displaying…
Read the full statement (133 words)
The EmbryoScope® time-lapse incubator (version D) provides an environment with controlled temperature, CO2 (and other gasses) for the development of embryos. This model has an integrated 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.
The EmbryoViewer™ software is an optional accessory software package for use in displaying, comparing, storing, and transferring images generated by the EmbryoScope® time-lapse incubator (Version D). The software includes a user annotation function for capturing information on embryo development parameters as well as a user-defined modeling function, which allows the user to combine annotated information on embryo development parameters to aid in embryo selection. The EmbryoViewer™ software does not control any hardware components in the EmbryoScope® time-lapse incubator (Version D).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K133712 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133712: Embryoviewer Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133712
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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