510(k) · Cleared
ClearedNunc Ivf Multidish 4 Wells Nunclon
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 Aug 12, 2004 after a 146-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 15 later devices descend from it.
- Decided
- Aug 12, 2004
- Review
- 146 days
- Class
- Class II
- Product code
- MQK
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 2 citing it directly.
- This deviceK040717 Nunc Ivf Multidish 4 Wells NunclonNunc A/S · 2004
- Descendant · cites it directly · 12 of its ownK070047 Nunc Ivf Dishes and Nunc Ivf 4-Well DishNunc A/S · 2007
- Descendant · 2 generations on · 11 of its ownK092183 Embryoscope and EmbryoslideUnisense Fertilitech A/S · 2011
- Descendant · 3 generations on · 9 of its ownK111715 EmbryoscopeUnisense Fertilitech A/S · 2011
- Descendant · 3 generations on · 8 of its ownK113075 Embryo Viewer SoftwareUnisense Fertilitech A/S · 2011
- Descendant · 3 generations on · 4 of its ownK150961 EmbryoSlide Culture DishVitrolife A/S · 2015
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K070047Nunc Ivf Dishes and Nunc Ivf 4-Well DishNunc A/S · 2007 · cites it directly12descendants
- K092183Embryoscope and EmbryoslideUnisense Fertilitech A/S · 2011 · 2 generations on11descendants
- K111715EmbryoscopeUnisense Fertilitech A/S · 2011 · 3 generations on9descendants
- K113075Embryo Viewer SoftwareUnisense Fertilitech A/S · 2011 · 3 generations on8descendants
- K150961EmbryoSlide Culture DishVitrolife A/S · 2015 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040717 | Nunc Ivf Multidish 4 Wells Nunclon | Nunc A/S | 2004 | — |
| +1 | K070047 | Nunc Ivf Dishes and Nunc Ivf 4-Well Dish | Nunc A/S | 2007 | — |
| +2 | K092183 | Embryoscope and Embryoslide | Unisense Fertilitech A/S | 2011 | — |
| +3 | K111715 | Embryoscope | Unisense Fertilitech A/S | 2011 | — |
| +3 | K113075 | Embryo Viewer Software | Unisense Fertilitech A/S | 2011 | — |
| +3 | K150961 | EmbryoSlide Culture Dish | Vitrolife A/S | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (15)
See all 152 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K070047 (Nunc A/S, 2007) has gone furthest, with 12 descendants of its own.
How does its category compare?
All MQK devicesMQK Labware, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 plate is a sterile non-pyrogenic, Embryotoxicity tested singleuse plasticware intended for preparing, storing, manipulating 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 510(k) statement.
https://510kreport.com/device/K040717 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040717: Nunc Ivf Multidish 4 Wells Nunclon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040717
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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