510(k) · Cleared
ClearedEsp Four Well Tissue Culture Plate, Esp Six Well Tissue Culture Plate, Esp Micro Six Well Tissue Culture Plate, Esp Well
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genesis Industries, Inc. · MQK Labware, Assisted Reproduction
Cleared on Feb 18, 2000 as substantially equivalent to K991249 (Becton Dickinson Labware, 1999) after a 53-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Feb 18, 2000
- Review
- 53 days
- Class
- Class II
- Product code
- MQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991249 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK991249 Falcon Ivf Four Well PlateBecton Dickinson Labware · 1999
- This deviceK994361 Esp Four Well Tissue Culture Plate, Esp Six Well Tissue Culture…Genesis Industries, Inc. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991249 | Falcon Ivf Four Well Plate | Becton Dickinson Labware | 1999 | — |
| 0 (this device) | K994361 | Esp Four Well Tissue Culture Plate, Esp Six Well Tissue Culture Plate, Esp… | Genesis Industries, Inc. | 2000 | — |
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
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- #2 Held for the reportin the report
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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 |
|---|---|---|---|
| * | K991249 | Falcon Ivf Four Well PlateSummary page 1…MQK Predicate Device Proprietary Name: Falcon IVF Four Well Plate Common Name: Cuture Dish Manufacturer: Becton Dickinson Labware Model Number: 353654 510(k) Number: K991249 Device Description The polystyrene ESP tissue culture plates consist of a square base plate with a square lid key wayed to inte… | 1999 |
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?
- Its one ancestor has no recall.
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 ESP Tissue Culture Plates are single-use labware intended for use in cell culturing and diagnostic laboratory procedures.
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/K994361 · printed Nov 5, 2026
Cite this page
510(k) Report. “K994361: Esp Four Well Tissue Culture Plate, Esp Six Well Tissue Culture Plate, Esp Micro Six Well Tissue Culture Plate, Esp Well.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K994361
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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