510(k) · Cleared
ClearedSpermcheck Fertility
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Princeton BioMeditech Corp. · POV Semen Analysis Device
Cleared on May 4, 2010 as substantially equivalent to K073039 (Princeton BioMeditech Corp., 2008) and 2 other predicates after an 88-day review. Its family tree reaches back 5 generations to 1994. 4 later devices descend from it.
- Decided
- May 4, 2010
- Review
- 88 days
- Class
- Class II
- Product code
- POV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K915229 (1994). 7 ancestors in all, the oldest K821186 (1982). 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK915229 Semen Analysis KitHumagen Fertility Diagnostics, Inc. · 1994
- 4 generations backK983473 Fertilmarq Test KitEmbryotech Laboratories, Inc. · 1998
- 3 generations backK011679 Fertilmarq Home Diagnostic Screening Test Kit for Male InfertilityEmbryotech Laboratories, Inc. · 2001
- 2 generations backK041039 Fertell Male Fertility TestGenosis, Ltd. · 2004
- 1 generation backK073039 Spermcheck VasectomyPrinceton BioMeditech Corp. · 2008
- This deviceK100341 Spermcheck FertilityPrinceton BioMeditech Corp. · 2010
- Descendant · cites it directly · 1 of its ownK161493 YO Home Sperm TestMedical Electronic Systems, Ltd. · 2016
- Descendant · cites it directly · 1 of its ownK153683 Trak Male Fertility Testing SystemSandstone Diagnostics, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK241628 YO Home Sperm TestMedical Electronic Systems, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK172514 Trak Plus Male Fertility Testing SystemSandstone Diagnostics, Inc. · 2017
Most influential descendants
Showing 4 of 4 · See all- K161493YO Home Sperm TestMedical Electronic Systems, Ltd. · 2016 · cites it directly1descendant
- K153683Trak Male Fertility Testing SystemSandstone Diagnostics, Inc. · 2016 · cites it directly1descendant
- K241628YO Home Sperm TestMedical Electronic Systems, Ltd. · 2024 · 2 generations on0descendants
- K172514Trak Plus Male Fertility Testing SystemSandstone Diagnostics, Inc. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K915229 | Semen Analysis Kit | Humagen Fertility Diagnostics, Inc. | 1994 | — |
| −4 | K983473 | Fertilmarq Test Kit | Embryotech Laboratories, Inc. | 1998 | — |
| −3 | K011679 | Fertilmarq Home Diagnostic Screening Test Kit for Male Infertility | Embryotech Laboratories, Inc. | 2001 | — |
| −2 | K041039 | Fertell Male Fertility Test | Genosis, Ltd. | 2004 | — |
| −1 | K073039 | Spermcheck Vasectomy | Princeton BioMeditech Corp. | 2008 | — |
| 0 (this device) | K100341 | Spermcheck Fertility | Princeton BioMeditech Corp. | 2010 | — |
| +1 | K161493 | YO Home Sperm Test | Medical Electronic Systems, Ltd. | 2016 | — |
| +1 | K153683 | Trak Male Fertility Testing System | Sandstone Diagnostics, Inc. | 2016 | — |
| +2 | K241628 | YO Home Sperm Test | Medical Electronic Systems, Ltd. | 2024 | — |
| +2 | K172514 | Trak Plus Male Fertility Testing System | Sandstone Diagnostics, Inc. | 2017 | — |
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 |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 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? (4)
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 |
|---|---|---|---|
| * | K073039 | Spermcheck VasectomySummary page 1…Semen analysis test device Classification Name: Obstetrics/gynecology Identification of legally marketed devices to which claims of equivalence are made: Hemacytometer K073039, SpermCheck® Vasectomy Test by Princeton BioMeditech Corp. K041039, Fertell Male Fertility Test by Genosis Ltd. ' K011679, FertiI… | 2008 |
| * | K041039 | Fertell Male Fertility TestSummary page 1…ogy Identification of legally marketed devices to which claims of equivalence are made: Hemacytometer K073039, SpermCheck® Vasectomy Test by Princeton BioMeditech Corp. K041039, Fertell Male Fertility Test by Genosis Ltd. ' K011679, FertiIMARQ™ Home Diagnostic Screening Test for Male Infertility, by Embry… | 2004 |
| * | K011679 | Fertilmarq Home Diagnostic Screening Test Kit for Male InfertilitySummary page 1…h claims of equivalence are made: Hemacytometer K073039, SpermCheck® Vasectomy Test by Princeton BioMeditech Corp. K041039, Fertell Male Fertility Test by Genosis Ltd. ' K011679, FertiIMARQ™ Home Diagnostic Screening Test for Male Infertility, by Embryotech Laboratories, Inc. Device Description: Sper;nChe… | 2001 |
| * | — | Hemacytometer Named without a submission number |
What descends from it? (4)
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?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K161493 (Medical Electronic Systems, Ltd., 2016) has gone furthest, with 1 descendant 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. 2010, 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?
SpermCheck® Fertility is a qualitative test that detects sperm concentration at or above 20,000,000 sperm/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 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/K100341 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100341: Spermcheck Fertility.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100341
Report an extraction error
Are you the manufacturer?
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