510(k) · Cleared
ClearedSwimCount Sperm Quality Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Motilitycount Aps · POV Semen Analysis Device
Cleared on Jun 27, 2019 as substantially equivalent to K041039 (Genosis, Ltd., 2004) after a 183-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Jun 27, 2019
- Review
- 183 days
- Class
- Class II
- Product code
- POV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K915229 (1994). 6 ancestors in all, the oldest K821186 (1982). No later device cites it as a predicate yet.
- Root · 4 generations backK915229 Semen Analysis KitHumagen Fertility Diagnostics, Inc. · 1994
- 3 generations backK983473 Fertilmarq Test KitEmbryotech Laboratories, Inc. · 1998
- 2 generations backK011679 Fertilmarq Home Diagnostic Screening Test Kit for Male InfertilityEmbryotech Laboratories, Inc. · 2001
- 1 generation backK041039 Fertell Male Fertility TestGenosis, Ltd. · 2004
- This deviceK183602 SwimCount Sperm Quality TestMotilitycount Aps · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915229 | Semen Analysis Kit | Humagen Fertility Diagnostics, Inc. | 1994 | — |
| −3 | K983473 | Fertilmarq Test Kit | Embryotech Laboratories, Inc. | 1998 | — |
| −2 | K011679 | Fertilmarq Home Diagnostic Screening Test Kit for Male Infertility | Embryotech Laboratories, Inc. | 2001 | — |
| −1 | K041039 | Fertell Male Fertility Test | Genosis, Ltd. | 2004 | — |
| 0 (this device) | K183602 | SwimCount Sperm Quality Test | Motilitycount Aps | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1992 | 1 | 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 POV? 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 POV device
- #1 K252228 Seaman Pro/Seamanscore 11.4 · 2 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 |
|---|---|---|---|
| * | K041039 | Fertell Male Fertility TestSummary page 5…Number Primary Genosis Ltd Fertell Male Fertility Test K041039 Device Description The SwimCount™ Sperm Quality Test is intended for in vitro, over-the-counter, use and is a pre- screening sp… | 2004 |
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 4 companies; a new generation was cleared every 4.3 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K041039.
How does its category compare?
All POV devicesPOV Semen Analysis Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · POV
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · POV
253in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · POV
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · POV
1in 2020
MAUDE reports naming product code POV, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 3 | 253 | 2 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The SwimCount™ Sperm Quality Test is a qualitative test that detects sperm concentration above or below 5,000,000
Progressive Motile Sperm Cells per mL (PMSCs/mL). The test is intended for use as an aid in the determination of a
man's fertility status. For in vitro, over-the-counter use.
The number of progressively motile sperm cells is only one factor that contributes to a male's fertility status. The
SwimCount™ Sperm Quality Test does not provide a complete evaluation of a male's fertility status. For a comprehensive
assessment of male fertility status then the patient should consult a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183602 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183602: SwimCount Sperm Quality Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183602
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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