510(k) · Cleared
ClearedFalcon Ivf Round Dish
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton Dickinson Labware · MQK Labware, Assisted Reproduction
Cleared on May 5, 1999 after a 22-day review. The FDA summary names no predicate by number. 3 later devices descend from it.
- Decided
- May 5, 1999
- Review
- 22 days
- Class
- Class II
- Product code
- MQK
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK991253 Falcon Ivf Round DishBecton Dickinson Labware · 1999
- Descendant · cites it directly · 1 of its ownK123641 Culture Dish 40 MM, Culture Dish 60 MM, Micro Droplet Culture Dish…Hertart · 2013
- Descendant · 2 generations on · 0 of its ownK150756 Micro well group culture dish, 9-well; Micro well group culture…Hertart · 2015
- Descendant · cites it directly · 0 of its ownK052457 Picsi Sperm Selection DeviceBiocoat, Inc. · 2006
Most influential descendants
Showing 3 of 3 · See all- K123641Culture Dish 40 MM, Culture Dish 60 MM, Micro Droplet Culture Dish, 5 Well Culture Dish…Hertart · 2013 · cites it directly1descendant
- K150756Micro well group culture dish, 9-well; Micro well group culture dish, 16-wellHertart · 2015 · 2 generations on0descendants
- K052457Picsi Sperm Selection DeviceBiocoat, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991253 | Falcon Ivf Round Dish | Becton Dickinson Labware | 1999 | — |
| +1 | K123641 | Culture Dish 40 MM, Culture Dish 60 MM, Micro Droplet Culture Dish, 5 Well… | Hertart | 2013 | — |
| +2 | K150756 | Micro well group culture dish, 9-well; Micro well group culture dish, 16-well | Hertart | 2015 | — |
| +1 | K052457 | Picsi Sperm Selection Device | Biocoat, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2013 | 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? (3)
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?
The FALCON® IVF Round Dish is sterile, nonpyrogenic, embryotoxicity tested, single-use plasticware intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF) or other assisted reproduction techniques.
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/K991253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991253: Falcon Ivf Round Dish.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991253
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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