510(k) · Cleared
ClearedFertell Male Fertility Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genosis, Ltd. · POV Semen Analysis Device
Cleared on Jul 20, 2004 as substantially equivalent to K821186 (Syva Co., 1982) and 3 other predicates after an 89-day review. Its family tree reaches back 3 generations to 1994. 7 later devices descend from it.
- Decided
- Jul 20, 2004
- Review
- 89 days
- Class
- Class II
- Product code
- POV
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K915229 (1994). 5 ancestors in all, the oldest K821186 (1982). 7 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK915229 Semen Analysis KitHumagen Fertility Diagnostics, Inc. · 1994
- 2 generations backK983473 Fertilmarq Test KitEmbryotech Laboratories, Inc. · 1998
- 1 generation backK011679 Fertilmarq Home Diagnostic Screening Test Kit for Male InfertilityEmbryotech Laboratories, Inc. · 2001
- This deviceK041039 Fertell Male Fertility TestGenosis, Ltd. · 2004
- Descendant · cites it directly · 5 of its ownK073039 Spermcheck VasectomyPrinceton BioMeditech Corp. · 2008
- Descendant · cites it directly · 4 of its ownK100341 Spermcheck FertilityPrinceton BioMeditech Corp. · 2010
- Descendant · 2 generations on · 1 of its ownK161493 YO Home Sperm TestMedical Electronic Systems, Ltd. · 2016
- Descendant · 2 generations on · 1 of its ownK153683 Trak Male Fertility Testing SystemSandstone Diagnostics, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK241628 YO Home Sperm TestMedical Electronic Systems, Ltd. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K073039Spermcheck VasectomyPrinceton BioMeditech Corp. · 2008 · cites it directly5descendants
- K100341Spermcheck FertilityPrinceton BioMeditech Corp. · 2010 · cites it directly4descendants
- K161493YO Home Sperm TestMedical Electronic Systems, Ltd. · 2016 · 2 generations on1descendant
- K153683Trak Male Fertility Testing SystemSandstone Diagnostics, Inc. · 2016 · 2 generations on1descendant
- K241628YO Home Sperm TestMedical Electronic Systems, Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K915229 | Semen Analysis Kit | Humagen Fertility Diagnostics, Inc. | 1994 | — |
| −2 | K983473 | Fertilmarq Test Kit | Embryotech Laboratories, Inc. | 1998 | — |
| −1 | K011679 | Fertilmarq Home Diagnostic Screening Test Kit for Male Infertility | Embryotech Laboratories, Inc. | 2001 | — |
| 0 (this device) | K041039 | Fertell Male Fertility Test | Genosis, Ltd. | 2004 | — |
| +1 | K073039 | Spermcheck Vasectomy | Princeton BioMeditech Corp. | 2008 | — |
| +1 | K100341 | Spermcheck Fertility | Princeton BioMeditech Corp. | 2010 | — |
| +2 | K161493 | YO Home Sperm Test | Medical Electronic Systems, Ltd. | 2016 | — |
| +2 | K153683 | Trak Male Fertility Testing System | Sandstone Diagnostics, Inc. | 2016 | — |
| +3 | K241628 | YO Home Sperm Test | Medical Electronic Systems, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 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? (5)
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 |
|---|---|---|---|
| * | K821186 | Penetrak TMSummary page 1…/classification name: Device, Semen Analysis Product code (classification): GKZ , Class 11 Legally Marketed Predicate Devices: Penetrak Cervical Mucus Penetration Test (K821186) FertiIMARQ Test kit (K011679) Hamilton Thorne IVOS (K920179) Humagen Semen Analysis Kit (K915229) Device Description and Tech… | 1982 |
| * | K011679 | Fertilmarq Home Diagnostic Screening Test Kit for Male InfertilitySummary page 1…Semen Analysis Product code (classification): GKZ , Class 11 Legally Marketed Predicate Devices: Penetrak Cervical Mucus Penetration Test (K821186) FertiIMARQ Test kit (K011679) Hamilton Thorne IVOS (K920179) Humagen Semen Analysis Kit (K915229) Device Description and Technological Characteristics: Th… | 2001 |
| * | K920719 | Ivos Analyzer Our OCR of the scanned summary read K920179, FDA’s number for Zippie P500 (Sunrise Medical Quickie Designs, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Hamilton Thorne IVOS”. | 1992 |
| * | K915229 | Semen Analysis KitSummary page 1…arketed Predicate Devices: Penetrak Cervical Mucus Penetration Test (K821186) FertiIMARQ Test kit (K011679) Hamilton Thorne IVOS (K920179) Humagen Semen Analysis Kit (K915229) Device Description and Technological Characteristics: The Fertell Male Fertility Test measures the concentration of progressiv… | 1994 |
| * | — | Sperm migration test (modified Kremer test) Named without a submission number |
What descends from it? (7)
3 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 10 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K073039 (Princeton BioMeditech Corp., 2008) has gone furthest, with 5 descendants of its own.
How does its category compare?
All POV devicesPOV Semen Analysis Device: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Fertell Male Fertility Test is intended to measure motile sperm in semen as an adjunctive screen of male fertility for over-the-counter (OTC) home use.
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/K041039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041039: Fertell Male Fertility Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041039
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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