510(k) · Cleared
ClearedTrak Male Fertility Testing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sandstone Diagnostics, Inc. · POV Semen Analysis Device
Cleared on May 16, 2016 as substantially equivalent to K100341 (Princeton BioMeditech Corp., 2010) after a 146-day review. Its family tree reaches back 6 generations to 1994. 1 later device descends from it.
- Decided
- May 16, 2016
- Review
- 146 days
- Class
- Class II
- Product code
- POV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K915229 (1994). 8 ancestors in all, the oldest K821186 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK915229 Semen Analysis KitHumagen Fertility Diagnostics, Inc. · 1994
- 5 generations backK983473 Fertilmarq Test KitEmbryotech Laboratories, Inc. · 1998
- 4 generations backK011679 Fertilmarq Home Diagnostic Screening Test Kit for Male InfertilityEmbryotech Laboratories, Inc. · 2001
- 3 generations backK041039 Fertell Male Fertility TestGenosis, Ltd. · 2004
- 2 generations backK073039 Spermcheck VasectomyPrinceton BioMeditech Corp. · 2008
- 1 generation backK100341 Spermcheck FertilityPrinceton BioMeditech Corp. · 2010
- This deviceK153683 Trak Male Fertility Testing SystemSandstone Diagnostics, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK172514 Trak Plus Male Fertility Testing SystemSandstone Diagnostics, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K172514Trak Plus Male Fertility Testing SystemSandstone Diagnostics, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K915229 | Semen Analysis Kit | Humagen Fertility Diagnostics, Inc. | 1994 | — |
| −5 | K983473 | Fertilmarq Test Kit | Embryotech Laboratories, Inc. | 1998 | — |
| −4 | K011679 | Fertilmarq Home Diagnostic Screening Test Kit for Male Infertility | Embryotech Laboratories, Inc. | 2001 | — |
| −3 | K041039 | Fertell Male Fertility Test | Genosis, Ltd. | 2004 | — |
| −2 | K073039 | Spermcheck Vasectomy | Princeton BioMeditech Corp. | 2008 | — |
| −1 | K100341 | Spermcheck Fertility | Princeton BioMeditech Corp. | 2010 | — |
| 0 (this device) | K153683 | Trak Male Fertility Testing System | Sandstone Diagnostics, Inc. | 2016 | — |
| +1 | 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 |
|---|---|---|
| 2017 | 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? (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 |
|---|---|---|---|
| * | K100341 | Spermcheck FertilitySummary page 4…2 (a)(3): Identification of the legally marketed predicate devices SpermCheck™ Fertility, Princeton Biomedtech Corp, Monmouth Junction, NJ, K100341 807.92 (a)(4): Device Description The Trak® Male Fertility Testing System (Trak) includes a small instrument (the Engine), dispo… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172514 | Trak Plus Male Fertility Testing System | 2017 | 0 |
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 22 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K172514 (Sandstone Diagnostics, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K100341.
How does its category compare?
All POV devicesPOV Semen Analysis Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
The Trak® Male Fertility Testing System is intended for semi-quantitative assessment of sperm concentration at 15
million sperm per milliliter (M/mL) or below, between 15 and 55 M/mL, and above 55 M/mL. Sperm concentration
is only one factor that could impact a man's fertility status and time to pregnancy. For complete assessment of male
reproductive health, the user should consult a physician. 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/K153683 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153683: Trak Male Fertility Testing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153683
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