POV — Semen Analysis Device Class II
Classification Details
- Product Code
- POV
- Device Class
- Class II
- Regulation Number
- 864.5220
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Definition
Device used to evaluate one or more human semen parameters including semen volume, sperm concentration, total sperm number, sperm motility, sperm morphology, sperm vitality, white blood cell concentration, and pH.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242830 | bonraybio co | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analy | May 30, 2025 |
| K242388 | bonraybio co | LensHooke X12 PRO Semen Analysis System | May 9, 2025 |
| K243114 | medical electronic systems | SQA-iOw Sperm Quality Analyzer | May 2, 2025 |
| K241628 | medical electronic systems | YO Home Sperm Test | November 29, 2024 |
| K220828 | medical electronic systems | SQA-iO Sperm Quality Analyzer | August 7, 2023 |
| K202089 | bonraybio co | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analy | October 28, 2020 |
| K183602 | motilitycount aps | SwimCount Sperm Quality Test | June 27, 2019 |
| K180343 | bonraybio co | LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer | November 16, 2018 |
| K172514 | sandstone diagnostics | Trak Plus Male Fertility Testing System | November 17, 2017 |
| K161493 | medical electronic systems | YO Home Sperm Test | November 8, 2016 |
| K153683 | sandstone diagnostics | Trak Male Fertility Testing System | May 16, 2016 |
| K100341 | princeton biomeditech | SPERMCHECK FERTILITY | May 4, 2010 |
| K073039 | princeton biomeditech | SPERMCHECK VASECTOMY | January 24, 2008 |
| K071737 | dyn-bioshaf (2006) | GENERAL SEMEN ANALYSIS KIT | October 25, 2007 |
| K063864 | medical electronic systems | QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS | March 26, 2007 |
| K041039 | genosis | FERTELL MALE FERTILITY TEST | July 20, 2004 |
| K032874 | biocoat | HBA SPERM-HYALURONAN BINDING ASSAY | November 24, 2003 |
| K024337 | bioshaf | GENERAL SEMEN ANALYSIS (GSA) KIT | July 3, 2003 |
| K021746 | medical electronic systems | SQA V, SPERM QUALITY ANALYZER | September 20, 2002 |
| K012805 | hamilton thorne research | AUTOMARQER | March 13, 2002 |