510(k) · Cleared
ClearedEmbryoSlide Culture 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 Dec 4, 2015 as substantially equivalent to K092183 (Unisense Fertilitech A/S, 2011) after a 238-day review. Its family tree reaches back 3 generations to 2004. 4 later devices descend from it.
- Decided
- Dec 4, 2015
- Review
- 238 days
- Class
- Class II
- Product code
- MQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K040717 (2004). 4 ancestors in all, the oldest K983642 (1999). 4 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 deviceK150961 EmbryoSlide Culture DishVitrolife A/S · 2015
- 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 |
|---|---|---|---|---|---|
| −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) | K150961 | EmbryoSlide Culture Dish | Vitrolife A/S | 2015 | — |
| +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 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 |
|---|---|---|---|
| * | K092183 | Embryoscope and EmbryoslideSummary page 4…on/Usual Name: IVF Incubator and Accessories Classification Name: Assisted Reproduction Labware (21 CFR 884.6160) 3. PREDICATE AND REFERENCE DEVICES • K092183, Vitrolife A/S EmbryoSlide culture dish (Predicate device) • K070047, Nunc IVF 4-Well Dish (Reference device) 4. DE… | 2011 |
| † | K070047 | Nunc Ivf Dishes and Nunc Ivf 4-Well Dish | 2007 |
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 11 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K173264 (Vitrolife A/S, 2018) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K092183.
How does its category compare?
All MQK devicesMQK Labware, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 culture dish is intended for preparing, storing, and transferring human embryos. It is intended to be used
only with the EmbryoScope device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150961: EmbryoSlide Culture Dish.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150961
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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