510(k) · Cleared
ClearedNunc Ivf Centerwell and Icsi Dishes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermo Fisher Scientific (Nalge Nunc Intl) · MQK Labware, Assisted Reproduction
Cleared on Sep 18, 2009 as substantially equivalent to K990941 (Humagen Fertility Diagnostics, Inc., 1999) after a 211-day review. Its family tree reaches back 1 generation to 1999. 10 later devices descend from it.
- Decided
- Sep 18, 2009
- Review
- 211 days
- Class
- Class II
- Product code
- MQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K990941 (1999). 10 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK990941 Newlife Dish (Etched or Non-Etched, with or Without Lid), Models…Humagen Fertility Diagnostics, Inc. · 1999
- This deviceK090429 Nunc Ivf Centerwell and Icsi DishesThermo Fisher Scientific (Nalge Nunc Intl) · 2009
- Descendant · cites it directly · 7 of its ownK112413 RI MSC (Migration Sedimentation Chamber)Research Instruments, Ltd. · 2012
- Descendant · 2 generations on · 5 of its ownK133295 QualisMenicon Co., Ltd. New Business Division · 2014
- Descendant · 3 generations on · 4 of its ownK173075 ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation…Dxnow, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK123641 Culture Dish 40 MM, Culture Dish 60 MM, Micro Droplet Culture Dish…Hertart · 2013
- Descendant · 4 generations on · 0 of its ownK241626 SperSort™ Sperm Sorting Chip (IPG02)Ipreg Incorporation · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K112413RI MSC (Migration Sedimentation Chamber)Research Instruments, Ltd. · 2012 · cites it directly7descendants
- K133295QualisMenicon Co., Ltd. New Business Division · 2014 · 2 generations on5descendants
- K173075ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)Dxnow, Inc. · 2018 · 3 generations on4descendants
- K123641Culture Dish 40 MM, Culture Dish 60 MM, Micro Droplet Culture Dish, 5 Well Culture Dish…Hertart · 2013 · cites it directly1descendant
- K241626SperSort™ Sperm Sorting Chip (IPG02)Ipreg Incorporation · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990941 | Newlife Dish (Etched or Non-Etched, with or Without Lid), Models 14-52, 1452E… | Humagen Fertility Diagnostics, Inc. | 1999 | — |
| 0 (this device) | K090429 | Nunc Ivf Centerwell and Icsi Dishes | Thermo Fisher Scientific (Nalge Nunc Intl) | 2009 | — |
| +1 | K112413 | RI MSC (Migration Sedimentation Chamber) | Research Instruments, Ltd. | 2012 | — |
| +2 | K133295 | Qualis | Menicon Co., Ltd. New Business Division | 2014 | — |
| +3 | K173075 | ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device… | Dxnow, Inc. | 2018 | — |
| +1 | K123641 | Culture Dish 40 MM, Culture Dish 60 MM, Micro Droplet Culture Dish, 5 Well… | Hertart | 2013 | — |
| +4 | K241626 | SperSort™ Sperm Sorting Chip (IPG02) | Ipreg Incorporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K990941 | Newlife Dish (Etched or Non-Etched, with or Without Lid), Models 14-52, 1452E, 1452EL…Summary page 1…s, Inc 2400 Hunter's Way Charlottesville, VA 22911 Catalog No. 14-52L 510(k) No. K990941 75 Panorama Creek Drive Rochester, NY Tel: 585.586.8800 wwAv.therrnofisher.com… | 1999 |
What descends from it? (10)
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?
- Its one ancestor has no recall.
- Of its descendants, K112413 (Research Instruments, Ltd., 2012) has gone furthest, with 7 descendants 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. 2009, 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 IVF Center Well Dish is intended for preparing and culturing gametes or embryos for use in human In Vitro Fertilization (IVF).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090429 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090429: Nunc Ivf Centerwell and Icsi Dishes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090429
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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