510(k) · Cleared
ClearedGenx Culture Dish
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
<Genx> Intl., Inc. · MQK Labware, Assisted Reproduction
Cleared on Feb 14, 2000 after a 90-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Feb 14, 2000
- Review
- 90 days
- Class
- Class II
- Product code
- MQK
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK993881 Genx Culture Dish<Genx> Intl., Inc. · 2000
- Descendant · cites it directly · 1 of its ownK123641 Culture Dish 40 MM, Culture Dish 60 MM, Micro Droplet Culture Dish…Hertart · 2013
- Descendant · cites it directly · 1 of its ownK103028 Eevatm Petri DishAuxogyn, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK150756 Micro well group culture dish, 9-well; Micro well group culture…Hertart · 2015
- Descendant · 2 generations on · 0 of its ownK141663 Eeva Dish (with 12 Microwells)Auxogyn, Inc. · 2014
Most influential descendants
Showing 4 of 4 · See all- K123641Culture Dish 40 MM, Culture Dish 60 MM, Micro Droplet Culture Dish, 5 Well Culture Dish…Hertart · 2013 · cites it directly1descendant
- K103028Eevatm Petri DishAuxogyn, Inc. · 2011 · cites it directly1descendant
- K150756Micro well group culture dish, 9-well; Micro well group culture dish, 16-wellHertart · 2015 · 2 generations on0descendants
- K141663Eeva Dish (with 12 Microwells)Auxogyn, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993881 | Genx Culture Dish | <Genx> Intl., Inc. | 2000 | — |
| +1 | K123641 | Culture Dish 40 MM, Culture Dish 60 MM, Micro Droplet Culture Dish, 5 Well… | Hertart | 2013 | — |
| +1 | K103028 | Eevatm Petri Dish | Auxogyn, Inc. | 2011 | — |
| +2 | K150756 | Micro well group culture dish, 9-well; Micro well group culture dish, 16-well | Hertart | 2015 | — |
| +2 | K141663 | Eeva Dish (with 12 Microwells) | Auxogyn, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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?
The FDA summary names no predicate by number.
What descends from it? (4)
2 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, K123641 (Hertart, 2013) has gone furthest, with 1 descendant 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?
To culture tissues and cells
May be used to hold sperm and culture embryos
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/K993881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993881: Genx 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/K993881
Report an extraction error
Are you the manufacturer?
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