510(k) · Cleared
ClearedMicro well group culture dish, 9-well; Micro well group culture dish, 16-well
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hertart · MQK Labware, Assisted Reproduction
Cleared on Jul 20, 2015 as substantially equivalent to K123641 (Hertart, 2013) after a 119-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Jul 20, 2015
- Review
- 119 days
- Class
- Class II
- Product code
- MQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K990941 (1999). 7 ancestors in all, the oldest K991253 (1999). No later device cites it as a predicate yet.
- Root · 3 generations backK990941 Newlife Dish (Etched or Non-Etched, with or Without Lid), Models…Humagen Fertility Diagnostics, Inc. · 1999
- 2 generations backK090429 Nunc Ivf Centerwell and Icsi DishesThermo Fisher Scientific (Nalge Nunc Intl) · 2009
- 1 generation backK123641 Culture Dish 40 MM, Culture Dish 60 MM, Micro Droplet Culture Dish…Hertart · 2013
- This deviceK150756 Micro well group culture dish, 9-well; Micro well group culture…Hertart · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K990941 | Newlife Dish (Etched or Non-Etched, with or Without Lid), Models 14-52, 1452E… | Humagen Fertility Diagnostics, Inc. | 1999 | — |
| −2 | K090429 | Nunc Ivf Centerwell and Icsi Dishes | Thermo Fisher Scientific (Nalge Nunc Intl) | 2009 | — |
| −1 | K123641 | Culture Dish 40 MM, Culture Dish 60 MM, Micro Droplet Culture Dish, 5 Well… | Hertart | 2013 | — |
| 0 (this device) | K150756 | Micro well group culture dish, 9-well; Micro well group culture dish, 16-well | Hertart | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K123641 | Culture Dish 40 MM, Culture Dish 60 MM, Micro Droplet Culture Dish, 5 Well Culture Dish…Summary page 4…ll group culture dish, 9-well Predicate Device: Proprietary Name: Vitrolife Micro Droplet Culture Dish Common Name: IVF Dish Manufacturer: HertART ApS 510(k) Number: K123641 Proposed Device: Micro well group culture dish, 16-well Predicate Device: Proprietary Name: Vitrolife Micro Droplet Culture Di… | 2013 |
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 16 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- None of the 7 ancestors has a recall.
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?
For in-vitro fertilisation, handling and embryo culture. It may be used for the culturing of embryos using drop culture
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/K150756 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150756: Micro well group culture dish, 9-well; Micro well group culture dish, 16-well.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150756
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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