510(k) · Cleared
ClearedGeneral Semen Analysis (Gsa) Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioshaf, Ltd. · POV Semen Analysis Device
Cleared on Jul 3, 2003 after a 188-day review. The FDA summary names no predicate by number.
- Decided
- Jul 3, 2003
- Review
- 188 days
- Class
- Class II
- Product code
- POV
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
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.
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 GSA Kit is for the evaluation of human semen. The kit provides the user with a set of reagents used to evaluate semen quality by measuring four (4) parameters recommended by the World Health Organization (WHO) that are used to determine whether infertility is caused by abnormalities of one or more of them. The parameters include: Sperm count Sperm motility Sperm vitality White blood cell (WBC) count In most fertility test laboratorics these…
Read the full statement (132 words)
The GSA Kit is for the evaluation of human semen. The kit provides the user with a set of reagents used to evaluate semen quality by measuring four (4) parameters recommended by the World Health Organization (WHO) that are used to determine whether infertility is caused by abnormalities of one or more of them. The parameters include:
Sperm count
Sperm motility
Sperm vitality
White blood cell (WBC) count
In most fertility test laboratorics these parameters are manually evaluated on a routine basis using a light microscope and a counting chamber. The performance characteristics of the GSA kit is based on a comparison between the GSA kit and the routine manual method performed according to the latest edition of the Manual for the Examination of Human Semen and Sperm published by the WHO.
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/K024337 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024337: General Semen Analysis (Gsa) Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024337
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026