510(k) · Cleared
ClearedNewlife Dish (Etched or Non-Etched, with or Without Lid), Models 14-52, 1452E, 1452EL, 1452L
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Humagen Fertility Diagnostics, Inc. · MQK Labware, Assisted Reproduction
Cleared on Jul 14, 1999 after a 114-day review. The FDA summary names no predicate by number. 11 later devices descend from it.
- Decided
- Jul 14, 1999
- Review
- 114 days
- Class
- Class II
- Product code
- MQK
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK990941 Newlife Dish (Etched or Non-Etched, with or Without Lid), Models…Humagen Fertility Diagnostics, Inc. · 1999
- Descendant · cites it directly · 10 of its ownK090429 Nunc Ivf Centerwell and Icsi DishesThermo Fisher Scientific (Nalge Nunc Intl) · 2009
- Descendant · 2 generations on · 7 of its ownK112413 RI MSC (Migration Sedimentation Chamber)Research Instruments, Ltd. · 2012
- Descendant · 3 generations on · 5 of its ownK133295 QualisMenicon Co., Ltd. New Business Division · 2014
- Descendant · 4 generations on · 4 of its ownK173075 ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation…Dxnow, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK123641 Culture Dish 40 MM, Culture Dish 60 MM, Micro Droplet Culture Dish…Hertart · 2013
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K090429Nunc Ivf Centerwell and Icsi DishesThermo Fisher Scientific (Nalge Nunc Intl) · 2009 · cites it directly10descendants
- K112413RI MSC (Migration Sedimentation Chamber)Research Instruments, Ltd. · 2012 · 2 generations on7descendants
- K133295QualisMenicon Co., Ltd. New Business Division · 2014 · 3 generations on5descendants
- K173075ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)Dxnow, Inc. · 2018 · 4 generations on4descendants
- K123641Culture Dish 40 MM, Culture Dish 60 MM, Micro Droplet Culture Dish, 5 Well Culture Dish…Hertart · 2013 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K112413 | RI MSC (Migration Sedimentation Chamber) | Research Instruments, Ltd. | 2012 | — |
| +3 | K133295 | Qualis | Menicon Co., Ltd. New Business Division | 2014 | — |
| +4 | K173075 | ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device… | Dxnow, Inc. | 2018 | — |
| +2 | K123641 | Culture Dish 40 MM, Culture Dish 60 MM, Micro Droplet Culture Dish, 5 Well… | Hertart | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 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?
The FDA summary names no predicate by number.
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090429 | Nunc Ivf Centerwell and Icsi Dishes | 2009 | 10 |
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, K090429 (Thermo Fisher Scientific (Nalge Nunc Intl), 2009) has gone furthest, with 10 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.
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 NewLife Dish's indication for use is to hold zygotes/embfyos during micromanipulation or other tissue culture procedures in the IVF laboratory.
NewLife Dishes are used in the tissue culture techniques performed by embryologists when injecting a single sperm into an egg, or assisting an embryo in hatching prior to re-implantation.
The dishes are disposable tissue culture labware used in procedures that have been developed to aid infertile couples achieve pregnancy. Specifically, the ICSI procedure is beneficial in cases where the male infertility is impaired.
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/K990941 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990941: Newlife Dish (Etched or Non-Etched, with or Without Lid), Models 14-52, 1452E, 1452EL, 1452L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990941
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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