510(k) · Cleared
ClearedCulture Dish 40 MM, Culture Dish 60 MM, Micro Droplet Culture Dish, 5 Well Culture Dish, Centre Well Dish, Icsi Dish
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 3, 2013 as substantially equivalent to K991253 (Becton Dickinson Labware, 1999) and 4 other predicates after a 219-day review. Its family tree reaches back 2 generations to 1999. 1 later device descends from it.
- Decided
- Jul 3, 2013
- Review
- 219 days
- Class
- Class II
- Product code
- MQK
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K990941 (1999). 6 ancestors in all, the oldest K991253 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK990941 Newlife Dish (Etched or Non-Etched, with or Without Lid), Models…Humagen Fertility Diagnostics, Inc. · 1999
- 1 generation backK090429 Nunc Ivf Centerwell and Icsi DishesThermo Fisher Scientific (Nalge Nunc Intl) · 2009
- This deviceK123641 Culture Dish 40 MM, Culture Dish 60 MM, Micro Droplet Culture Dish…Hertart · 2013
- Descendant · cites it directly · 0 of its ownK150756 Micro well group culture dish, 9-well; Micro well group culture…Hertart · 2015
Most influential descendants
Showing 1 of 1 · See all- K150756Micro well group culture dish, 9-well; Micro well group culture dish, 16-wellHertart · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K990941 | Newlife Dish (Etched or Non-Etched, with or Without Lid), Models 14-52, 1452E… | Humagen Fertility Diagnostics, Inc. | 1999 | — |
| −1 | K090429 | Nunc Ivf Centerwell and Icsi Dishes | Thermo Fisher Scientific (Nalge Nunc Intl) | 2009 | — |
| 0 (this device) | K123641 | Culture Dish 40 MM, Culture Dish 60 MM, Micro Droplet Culture Dish, 5 Well… | Hertart | 2013 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K991253 | Falcon Ivf Round DishSummary page 3…t Device - Vitrolife Predicate Device - Falcon Differences Cuiture.Dish 60 mm IVF Round Dish (K991253) __________ Device Round petri dish with diameter Round petri dish with diameter… | 1999 |
| * | K040717 | Nunc Ivf Multidish 4 Wells NunclonSummary page 1…ii PREDICATE DEVICES Falcon IVF Round Dish (K(991253) for Vitrolife Culture Dish 60 mm & Vitrolife Culture Dish 40 mm Nunc IVE Multidish 4 Wells Nunclon (K040717) for Vitrolife 5 Well Culture Dish Nunc IVF ICSI Dish (K0429) for Vitrolife ICSI Dish Falcon IVF One Well Dish (K(991251) for Vit… | 2004 |
| * | K090429 | Nunc Ivf Centerwell and Icsi DishesSummary page 5…Subject Device - Vitrolife Predicate Device - Nunc IVF Differences ICSI Dish ICSI Dish (K090429) __________ Device Square dish with 1 well with Round dish with 1 round well Proposed… | 2009 |
| * | K991251 | Falcon Ivf One Well DishSummary page 6…ce - Falcon Differences Centre Well Dish IVF One Well Dish ___________(K991251) Device Square dish with 1 oval well Round dish with 1 round well Proposed device ha… | 1999 |
| * | K993881 | Genx Culture DishSummary page 7…Micro Droplet Culture Dish Culture Dish (Sun IVF _____________________Embryo Corral)_K993881) Device Square dish with 12 round Round dish with 11 round wells Proposed device has… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150756 | Micro well group culture dish, 9-well; Micro well group culture dish, 16-well | 2015 | 0 |
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 14 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K150756 (Hertart, 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K991253.
How does its category compare?
All MQK devicesMQK Labware, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
The Vitrolife Culture Dishes are Intended for IVF, suitable for use in preparing, storing, manipulating, or transferring human gametes or embryos for in vitro fertilization (IVF), gamete intrafalloplan transfer (GIFT), or other reproduction procedures. The Vltrolife 5 Well Culture Dish Is Intended for IVF, suitable for preparing, storing, manipulating or transferring human gametes or embryos for in vitro fertilization (IVF), or other in vitro…
Read the full statement (112 words)
The Vitrolife Culture Dishes are Intended for IVF, suitable for use in preparing, storing, manipulating, or transferring human gametes or embryos for in vitro fertilization (IVF), gamete intrafalloplan transfer (GIFT), or other reproduction procedures.
The Vltrolife 5 Well Culture Dish Is Intended for IVF, suitable for preparing, storing, manipulating or transferring human gametes or embryos for in vitro fertilization (IVF), or other in vitro fertilization techniques.
The Vitrolife ICSI Dish is intended for IVF, suitable for holding oocytes and sperm during fertilization via intracytoplasmic sperm Injection (ICSI).
The Vitralife Micro Droplet Culture Dish Is Intended for IVF. It may be used with sperm and for the culturing of embryos using drop culture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123641 · printed Nov 3, 2026
Cite this page
510(k) Report. “K123641: Culture Dish 40 MM, Culture Dish 60 MM, Micro Droplet Culture Dish, 5 Well Culture Dish, Centre Well Dish, Icsi Dish.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K123641
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