510(k) · Cleared
ClearedRI MSC (Migration Sedimentation Chamber)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Research Instruments, Ltd. · MQK Labware, Assisted Reproduction
Cleared on Jul 13, 2012 as substantially equivalent to K090429 (Thermo Fisher Scientific (Nalge Nunc Intl), 2009) after a 326-day review. Its family tree reaches back 2 generations to 1999. 7 later devices descend from it.
- Decided
- Jul 13, 2012
- Review
- 326 days
- Class
- Class II
- Product code
- MQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K990941 (1999). 7 later devices descend from it, 2 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 deviceK112413 RI MSC (Migration Sedimentation Chamber)Research Instruments, Ltd. · 2012
- Descendant · cites it directly · 5 of its ownK133295 QualisMenicon Co., Ltd. New Business Division · 2014
- Descendant · 2 generations on · 4 of its ownK173075 ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation…Dxnow, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK241626 SperSort™ Sperm Sorting Chip (IPG02)Ipreg Incorporation · 2025
- Descendant · 3 generations on · 0 of its ownK241348 SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)Motilitycount Aps · 2025
- Descendant · 3 generations on · 0 of its ownK232980 SpermAlign Sperm Separation DeviceCytoswim, Ltd. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K133295QualisMenicon Co., Ltd. New Business Division · 2014 · cites it directly5descendants
- K173075ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)Dxnow, Inc. · 2018 · 2 generations on4descendants
- K241626SperSort™ Sperm Sorting Chip (IPG02)Ipreg Incorporation · 2025 · 3 generations on0descendants
- K241348SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)Motilitycount Aps · 2025 · 3 generations on0descendants
- K232980SpermAlign Sperm Separation DeviceCytoswim, Ltd. · 2024 · 3 generations on0descendants
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) | K112413 | RI MSC (Migration Sedimentation Chamber) | Research Instruments, Ltd. | 2012 | — |
| +1 | K133295 | Qualis | Menicon Co., Ltd. New Business Division | 2014 | — |
| +2 | K173075 | ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device… | Dxnow, Inc. | 2018 | — |
| +3 | K241626 | SperSort™ Sperm Sorting Chip (IPG02) | Ipreg Incorporation | 2025 | — |
| +3 | K241348 | SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) | Motilitycount Aps | 2025 | — |
| +3 | K232980 | SpermAlign Sperm Separation Device | Cytoswim, Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K090429 | Nunc Ivf Centerwell and Icsi DishesSummary page 1…rmo Fisher Scientific (Nalge Nunc International) Classification Name: Labware, Assisted Reproduction (21CFR 884.6160, 85 MQK) 510(K): K(090429 Page 1 of 4 FDA 510K RI MSC-06412… | 2009 |
What descends from it? (7)
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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K133295 (Menicon Co., Ltd. New Business Division, 2014) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K090429.
How does its category compare?
All MQK devicesMQK Labware, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 RI MVSC is intended to prepare sperm by migration-sedimentation method for the assisted reproduction techniques of intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) and intrauterine insemination (IUI).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112413 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112413: RI MSC (Migration Sedimentation Chamber).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112413
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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