510(k) · Cleared
ClearedFertilmarq Test Kit
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 Dec 17, 1998 as substantially equivalent to K915229 (Humagen Fertility Diagnostics, Inc., 1994) after a 76-day review. Its family tree reaches back 1 generation to 1994. 9 later devices descend from it.
- Decided
- Dec 17, 1998
- Review
- 76 days
- Class
- Class II
- Product code
- POV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915229 (1994). 9 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK915229 Semen Analysis KitHumagen Fertility Diagnostics, Inc. · 1994
- This deviceK983473 Fertilmarq Test KitEmbryotech Laboratories, Inc. · 1998
- Descendant · cites it directly · 8 of its ownK011679 Fertilmarq Home Diagnostic Screening Test Kit for Male InfertilityEmbryotech Laboratories, Inc. · 2001
- Descendant · 2 generations on · 7 of its ownK041039 Fertell Male Fertility TestGenosis, Ltd. · 2004
- Descendant · 2 generations on · 5 of its ownK073039 Spermcheck VasectomyPrinceton BioMeditech Corp. · 2008
- Descendant · 2 generations on · 4 of its ownK100341 Spermcheck FertilityPrinceton BioMeditech Corp. · 2010
- Descendant · 3 generations on · 1 of its ownK161493 YO Home Sperm TestMedical Electronic Systems, Ltd. · 2016
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K011679Fertilmarq Home Diagnostic Screening Test Kit for Male InfertilityEmbryotech Laboratories, Inc. · 2001 · cites it directly8descendants
- K041039Fertell Male Fertility TestGenosis, Ltd. · 2004 · 2 generations on7descendants
- K073039Spermcheck VasectomyPrinceton BioMeditech Corp. · 2008 · 2 generations on5descendants
- K100341Spermcheck FertilityPrinceton BioMeditech Corp. · 2010 · 2 generations on4descendants
- K161493YO Home Sperm TestMedical Electronic Systems, Ltd. · 2016 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915229 | Semen Analysis Kit | Humagen Fertility Diagnostics, Inc. | 1994 | — |
| 0 (this device) | K983473 | Fertilmarq Test Kit | Embryotech Laboratories, Inc. | 1998 | — |
| +1 | K011679 | Fertilmarq Home Diagnostic Screening Test Kit for Male Infertility | Embryotech Laboratories, Inc. | 2001 | — |
| +2 | K041039 | Fertell Male Fertility Test | Genosis, Ltd. | 2004 | — |
| +2 | K073039 | Spermcheck Vasectomy | Princeton BioMeditech Corp. | 2008 | — |
| +2 | K100341 | Spermcheck Fertility | Princeton BioMeditech Corp. | 2010 | — |
| +3 | K161493 | YO Home Sperm Test | Medical Electronic Systems, Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K915229 | Semen Analysis KitSummary page 1…sual name: Semen analysis test kit Classification name: Obstetrics/gynecology (3) Legally marketed predicate device: Semen Analysis Kit [Humagen Fertility Diagnostics] (K915229, 08/30/94) (4) Subject device description; The FertiIMARQ™ Test Kit is an in vitro test kit for the analysis of sperm concentra… | 1994 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011679 | Fertilmarq Home Diagnostic Screening Test Kit for Male Infertility | 2001 | 8 |
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?
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 FertilMARQ™ Test Kit is a semi-quantitative test for the rapid analysis of sperm concentration to aid in the determination 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/K983473 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983473: Fertilmarq Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983473
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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