510(k) · Cleared
ClearedNunc Ivf Dishes and Nunc Ivf 4-Well Dish
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nunc A/S · MQK Labware, Assisted Reproduction
Cleared on May 18, 2007 as substantially equivalent to K040717 (Nunc A/S, 2004) after a 134-day review. Its family tree reaches back 1 generation to 2004. 12 later devices descend from it.
- Decided
- May 18, 2007
- Review
- 134 days
- Class
- Class II
- Product code
- MQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K040717 (2004). 12 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK040717 Nunc Ivf Multidish 4 Wells NunclonNunc A/S · 2004
- This deviceK070047 Nunc Ivf Dishes and Nunc Ivf 4-Well DishNunc A/S · 2007
- Descendant · cites it directly · 11 of its ownK092183 Embryoscope and EmbryoslideUnisense Fertilitech A/S · 2011
- Descendant · 2 generations on · 9 of its ownK111715 EmbryoscopeUnisense Fertilitech A/S · 2011
- Descendant · 2 generations on · 8 of its ownK113075 Embryo Viewer SoftwareUnisense Fertilitech A/S · 2011
- Descendant · 2 generations on · 4 of its ownK150961 EmbryoSlide Culture DishVitrolife A/S · 2015
- Descendant · 3 generations on · 4 of its ownK133712 Embryoviewer SoftwareUnisense Fertilitech A/S · 2014
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K092183Embryoscope and EmbryoslideUnisense Fertilitech A/S · 2011 · cites it directly11descendants
- K111715EmbryoscopeUnisense Fertilitech A/S · 2011 · 2 generations on9descendants
- K113075Embryo Viewer SoftwareUnisense Fertilitech A/S · 2011 · 2 generations on8descendants
- K150961EmbryoSlide Culture DishVitrolife A/S · 2015 · 2 generations on4descendants
- K133712Embryoviewer SoftwareUnisense Fertilitech A/S · 2014 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040717 | Nunc Ivf Multidish 4 Wells Nunclon | Nunc A/S | 2004 | — |
| 0 (this device) | K070047 | Nunc Ivf Dishes and Nunc Ivf 4-Well Dish | Nunc A/S | 2007 | — |
| +1 | K092183 | Embryoscope and Embryoslide | Unisense Fertilitech A/S | 2011 | — |
| +2 | K111715 | Embryoscope | Unisense Fertilitech A/S | 2011 | — |
| +2 | K113075 | Embryo Viewer Software | Unisense Fertilitech A/S | 2011 | — |
| +2 | K150961 | EmbryoSlide Culture Dish | Vitrolife A/S | 2015 | — |
| +3 | K133712 | Embryoviewer Software | Unisense Fertilitech A/S | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 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 |
|---|---|---|---|
| * | K040717 | Nunc Ivf Multidish 4 Wells NunclonSummary page 1…ame Nunc IVF Multidish 4 Well Nunclon Common name Plastic single use labware dish Manufacturer Nunc A/S Catalogue No 144444 510(k) No. K040717 510(k) application. Nunc A/S, Kamstrupvej 90, DK-4000 Roskilde, Denmark Section E - Summary… | 2004 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092183 | Embryoscope and Embryoslide | 2011 | 11 |
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?
How does its category compare?
All MQK devicesMQK Labware, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Nunc IVF 4-Well Dishes are intended for preparing, storing, manipulation or transferring human gametes or embryos for in-vitro fertilization (IVF), or other in vitro fertilization techniques and cell culture.
Nunc IVF PetriDishes are intended for preparing, storing, manipulation or transferring human gametes or embryos for in-vitro fertilization (IVF), or other in vitro fertilization techniques and cell culture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070047 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070047: Nunc Ivf Dishes and Nunc Ivf 4-Well Dish.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070047
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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