510(k) · Cleared
ClearedQualis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Menicon Co., Ltd. New Business Division · MQK Labware, Assisted Reproduction
Cleared on Jun 18, 2014 as substantially equivalent to K112413 (Research Instruments, Ltd., 2012) after a 236-day review. Its family tree reaches back 3 generations to 1999. 5 later devices descend from it.
- Decided
- Jun 18, 2014
- Review
- 236 days
- Class
- Class II
- Product code
- MQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K990941 (1999). 5 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK990941 Newlife Dish (Etched or Non-Etched, with or Without Lid), Models…Humagen Fertility Diagnostics, Inc. · 1999
- 2 generations backK090429 Nunc Ivf Centerwell and Icsi DishesThermo Fisher Scientific (Nalge Nunc Intl) · 2009
- 1 generation backK112413 RI MSC (Migration Sedimentation Chamber)Research Instruments, Ltd. · 2012
- This deviceK133295 QualisMenicon Co., Ltd. New Business Division · 2014
- Descendant · cites it directly · 4 of its ownK173075 ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation…Dxnow, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK241626 SperSort™ Sperm Sorting Chip (IPG02)Ipreg Incorporation · 2025
- Descendant · 2 generations on · 0 of its ownK241348 SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)Motilitycount Aps · 2025
- Descendant · 2 generations on · 0 of its ownK232980 SpermAlign Sperm Separation DeviceCytoswim, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK221810 LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm…Bonraybio Co., Ltd. · 2022
Most influential descendants
Showing 5 of 5 · See all- K173075ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)Dxnow, Inc. · 2018 · cites it directly4descendants
- K241626SperSort™ Sperm Sorting Chip (IPG02)Ipreg Incorporation · 2025 · 2 generations on0descendants
- K241348SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)Motilitycount Aps · 2025 · 2 generations on0descendants
- K232980SpermAlign Sperm Separation DeviceCytoswim, Ltd. · 2024 · 2 generations on0descendants
- K221810LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation DeviceBonraybio Co., Ltd. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K990941 | Newlife Dish (Etched or Non-Etched, with or Without Lid), Models 14-52, 1452E… | Humagen Fertility Diagnostics, Inc. | 1999 | — |
| −2 | 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 | — |
| 0 (this device) | K133295 | Qualis | Menicon Co., Ltd. New Business Division | 2014 | — |
| +1 | K173075 | ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device… | Dxnow, Inc. | 2018 | — |
| +2 | K241626 | SperSort™ Sperm Sorting Chip (IPG02) | Ipreg Incorporation | 2025 | — |
| +2 | K241348 | SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) | Motilitycount Aps | 2025 | — |
| +2 | K232980 | SpermAlign Sperm Separation Device | Cytoswim, Ltd. | 2024 | — |
| +2 | K221810 | LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device | Bonraybio Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K112413 | RI MSC (Migration Sedimentation Chamber)Summary page 1…884.6160, Assisted Reproduction L.abxvare Product MQK Code: Predicate IThe subject device is equivalent to the following devices: Device(s): KI 112413, Research Instruments Migration Sedimentation Chamber Device The Qualis is a sterile, disposable, plastic laboratory d… | 2012 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173075 | ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) | 2018 | 4 |
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 15 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K173075 (Dxnow, Inc., 2018) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K112413.
How does its category compare?
All MQK devicesMQK Labware, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Quais is intended for preparing motile human sperm for use in the treatment of infertile couples by intracytoplasmic sperm insertion (ICSI) fertilization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133295 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133295: Qualis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133295
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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