510(k) · Cleared
ClearedFertilmarq Home Diagnostic Screening Test Kit for Male Infertility
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Embryotech Laboratories, Inc. · POV Semen Analysis Device
Cleared on Aug 15, 2001 as substantially equivalent to K983473 (Embryotech Laboratories, Inc., 1998) after a 77-day review. Its family tree reaches back 2 generations to 1994. 8 later devices descend from it.
- Decided
- Aug 15, 2001
- Review
- 77 days
- Class
- Class II
- Product code
- POV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K915229 (1994). 8 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK915229 Semen Analysis KitHumagen Fertility Diagnostics, Inc. · 1994
- 1 generation backK983473 Fertilmarq Test KitEmbryotech Laboratories, Inc. · 1998
- This deviceK011679 Fertilmarq Home Diagnostic Screening Test Kit for Male InfertilityEmbryotech Laboratories, Inc. · 2001
- Descendant · cites it directly · 7 of its ownK041039 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
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K041039Fertell Male Fertility TestGenosis, Ltd. · 2004 · cites it directly7descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K915229 | Semen Analysis Kit | Humagen Fertility Diagnostics, Inc. | 1994 | — |
| −1 | K983473 | Fertilmarq Test Kit | Embryotech Laboratories, Inc. | 1998 | — |
| 0 (this device) | K011679 | Fertilmarq Home Diagnostic Screening Test Kit for Male Infertility | Embryotech Laboratories, Inc. | 2001 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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 11.5 · 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 |
|---|---|---|---|
| * | K983473 | Fertilmarq Test KitSummary page 1…emen analysis test kit Classification name: Obstetrics/gynecology (3) Legally marketed predicate device: Embryotech FertilMARQ™ Test Kit [Embryotech Laboratories, Inc. (K983473, 12/17/98)] (4) Subject device description: The FertiiMARQ™ Home Diagnostic Screening Test Kit for Male Infertility is an in v… | 1998 |
What descends from it? (8)
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 7 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K041039 (Genosis, Ltd., 2004) has gone furthest, with 7 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 FertiiMARQ™ Home Diagnostic Screening Test Kit for Male Infertility is a
rapid test of your semen for sperm concentration. It will measure sperm as either
above or below the cutoff of 20 million sperm cells per milliliter (mL). Two test
results of less than 20 million cells/mL are an indicator of male infertility
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/K011679 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011679: Fertilmarq Home Diagnostic Screening Test Kit for Male Infertility.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011679
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026