510(k) · Cleared
ClearedSemen Analysis Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Humagen Fertility Diagnostics, Inc. · POV Semen Analysis Device
Cleared on Aug 30, 1994 after a 1,014-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 10 later devices descend from it.
- Decided
- Aug 30, 1994
- Review
- 1,014 days
- Class
- Class II
- Product code
- POV
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK915229 Semen Analysis KitHumagen Fertility Diagnostics, Inc. · 1994
- Descendant · cites it directly · 9 of its ownK983473 Fertilmarq Test KitEmbryotech Laboratories, Inc. · 1998
- Descendant · 2 generations on · 8 of its ownK011679 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 · 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
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K983473Fertilmarq Test KitEmbryotech Laboratories, Inc. · 1998 · cites it directly9descendants
- K011679Fertilmarq Home Diagnostic Screening Test Kit for Male InfertilityEmbryotech Laboratories, Inc. · 2001 · 2 generations on8descendants
- K041039Fertell Male Fertility TestGenosis, Ltd. · 2004 · cites it directly7descendants
- K073039Spermcheck VasectomyPrinceton BioMeditech Corp. · 2008 · 2 generations on5descendants
- K100341Spermcheck FertilityPrinceton BioMeditech Corp. · 2010 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915229 | Semen Analysis Kit | Humagen Fertility Diagnostics, Inc. | 1994 | — |
| +1 | 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 | — |
| +2 | K073039 | Spermcheck Vasectomy | Princeton BioMeditech Corp. | 2008 | — |
| +2 | K100341 | Spermcheck Fertility | Princeton BioMeditech Corp. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (10)
2 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?
- Of its descendants, K983473 (Embryotech Laboratories, Inc., 1998) has gone furthest, with 9 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 | — |
https://510kreport.com/device/K915229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K915229: Semen Analysis Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915229
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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