510(k) · Cleared
ClearedSpermAlign Sperm Separation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cytoswim, Ltd. · MQK Labware, Assisted Reproduction
Cleared on Mar 14, 2024 as substantially equivalent to K173075 (Dxnow, Inc., 2018) after a 175-day review. Its family tree reaches back 5 generations to 1999.
- Decided
- Mar 14, 2024
- Review
- 175 days
- Class
- Class II
- Product code
- MQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K990941 (1999). No later device cites it as a predicate yet.
- Root · 5 generations backK990941 Newlife Dish (Etched or Non-Etched, with or Without Lid), Models…Humagen Fertility Diagnostics, Inc. · 1999
- 4 generations backK090429 Nunc Ivf Centerwell and Icsi DishesThermo Fisher Scientific (Nalge Nunc Intl) · 2009
- 3 generations backK112413 RI MSC (Migration Sedimentation Chamber)Research Instruments, Ltd. · 2012
- 2 generations backK133295 QualisMenicon Co., Ltd. New Business Division · 2014
- 1 generation backK173075 ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation…Dxnow, Inc. · 2018
- This deviceK232980 SpermAlign Sperm Separation DeviceCytoswim, Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K990941 | Newlife Dish (Etched or Non-Etched, with or Without Lid), Models 14-52, 1452E… | Humagen Fertility Diagnostics, Inc. | 1999 | — |
| −4 | K090429 | Nunc Ivf Centerwell and Icsi Dishes | Thermo Fisher Scientific (Nalge Nunc Intl) | 2009 | — |
| −3 | K112413 | RI MSC (Migration Sedimentation Chamber) | Research Instruments, Ltd. | 2012 | — |
| −2 | K133295 | Qualis | Menicon Co., Ltd. New Business Division | 2014 | — |
| −1 | K173075 | ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device… | Dxnow, Inc. | 2018 | — |
| 0 (this device) | K232980 | SpermAlign Sperm Separation Device | Cytoswim, Ltd. | 2024 | — |
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 |
|---|---|---|---|
| * | K173075 | ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)Summary page 5…510(k) Number ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) K173075 The predicate device has not been subject to a design-related recall.… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 6 companies; a new generation was cleared every 3.7 years on median.
- None of the 5 ancestors has a recall.
- 3 other devices also cite its predicate K173075.
How does its category compare?
All MQK devicesMQK Labware, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 SpermAlign Sperm Separation Device is intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI) and in vitro fertilization (IVF) procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232980 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232980: SpermAlign Sperm Separation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232980
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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