510(k) · Cleared
ClearedEmbryoSlide+ ic8 dish
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitrolife A/S · MQK Labware, Assisted Reproduction
Cleared on Mar 11, 2022 as substantially equivalent to K173264 (Vitrolife A/S, 2018) after an 88-day review. Its family tree reaches back 7 generations to 2004.
- Decided
- Mar 11, 2022
- Review
- 88 days
- Class
- Class II
- Product code
- MQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K040717 (2004). 9 ancestors in all, the oldest K983642 (1999). No later device cites it as a predicate yet.
- Root · 7 generations backK040717 Nunc Ivf Multidish 4 Wells NunclonNunc A/S · 2004
- 6 generations backK070047 Nunc Ivf Dishes and Nunc Ivf 4-Well DishNunc A/S · 2007
- 5 generations backK092183 Embryoscope and EmbryoslideUnisense Fertilitech A/S · 2011
- 4 generations backK111715 EmbryoscopeUnisense Fertilitech A/S · 2011
- 3 generations backK113075 Embryo Viewer SoftwareUnisense Fertilitech A/S · 2011
- 2 generations backK133712 Embryoviewer SoftwareUnisense Fertilitech A/S · 2014
- 1 generation backK173264 EmbryoScope+Vitrolife A/S · 2018
- This deviceK213869 EmbryoSlide+ ic8 dishVitrolife A/S · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K040717 | Nunc Ivf Multidish 4 Wells Nunclon | Nunc A/S | 2004 | — |
| −6 | K070047 | Nunc Ivf Dishes and Nunc Ivf 4-Well Dish | Nunc A/S | 2007 | — |
| −5 | K092183 | Embryoscope and Embryoslide | Unisense Fertilitech A/S | 2011 | — |
| −4 | K111715 | Embryoscope | Unisense Fertilitech A/S | 2011 | — |
| −3 | K113075 | Embryo Viewer Software | Unisense Fertilitech A/S | 2011 | — |
| −2 | K133712 | Embryoviewer Software | Unisense Fertilitech A/S | 2014 | — |
| −1 | K173264 | EmbryoScope+ | Vitrolife A/S | 2018 | — |
| 0 (this device) | K213869 | EmbryoSlide+ ic8 dish | Vitrolife A/S | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2015 | 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 MQK? 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 MQK device
- #1 K241626 SperSort™ Sperm Sorting Chip (IPG02)score 10.1 · 5 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 |
|---|---|---|---|
| * | K173264 | EmbryoScope+Summary page 4…Labware Product Code MQK (Labware, Assisted Reproduction) Regulatory Class II 4. PREDICATE DEVICE EmbryoSlide+ culture dish, K173264, (Vitrolife A/S). The predicate device has not been subject to a design-related recall.… | 2018 |
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 18 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 2 other devices also cite its predicate K173264.
How does its category compare?
All MQK devicesMQK Labware, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · MQK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQK
259in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQK
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQK
1in 2025
MAUDE reports naming product code MQK, 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 | 1 | — | 1 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 0 |
| 2012 | 3 | 454 | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 6 | 270 | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 4 | 154 | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 4 | 163 | 0 | 0 |
| 2025 | 3 | 259 | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The EmbryoSlide+ ic8 dish is intended for culturing, handling and preparation for transfer of human embryos. The EmbryoSlide+ ic8 dish must be used together with the EmbryoScope+ incubator.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213869 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213869: EmbryoSlide+ ic8 dish.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213869
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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