Product code POV
- Device name
- Semen Analysis Device
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.5220
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242830 | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer | Bonraybio Co., Ltd. | 2025-05-30 |
| K242388 | LensHooke X12 PRO Semen Analysis System | Bonraybio Co., Ltd. | 2025-05-09 |
| K243114 | SQA-iOw Sperm Quality Analyzer | Medical Electronic Systems , Ltd. | 2025-05-02 |
| K241628 | YO Home Sperm Test | Medical Electronic Systems , Ltd. | 2024-11-29 |
| K220828 | SQA-iO Sperm Quality Analyzer | Medical Electronic Systems , Ltd. | 2023-08-07 |
| K202089 | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer | Bonraybio Co., Ltd. | 2020-10-28 |
| K183602 | SwimCount Sperm Quality Test | Motilitycount Aps | 2019-06-27 |
| K180343 | LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer | Bonraybio Co., Ltd. | 2018-11-16 |
| K172514 | Trak Plus Male Fertility Testing System | Sandstone Diagnostics, Inc. | 2017-11-17 |
| K161493 | YO Home Sperm Test | Medical Electronic Systems , Ltd. | 2016-11-08 |
| K153683 | Trak Male Fertility Testing System | Sandstone Diagnostics, Inc. | 2016-05-16 |
| K100341 | SPERMCHECK FERTILITY | Princeton BioMeditech Corp. | 2010-05-04 |
| K073039 | SPERMCHECK VASECTOMY | Princeton BioMeditech Corp. | 2008-01-24 |
| K071737 | GENERAL SEMEN ANALYSIS KIT | Dyn-Bioshaf (2006) , Ltd. | 2007-10-25 |
| K063864 | QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS | Medical Electronic Systems , Ltd. | 2007-03-26 |
| K041039 | FERTELL MALE FERTILITY TEST | Genosis , Ltd. | 2004-07-20 |
| K032874 | HBA SPERM-HYALURONAN BINDING ASSAY | Biocoat, Inc. | 2003-11-24 |
| K024337 | GENERAL SEMEN ANALYSIS (GSA) KIT | Bioshaf , Ltd. | 2003-07-03 |
| K021746 | SQA V, SPERM QUALITY ANALYZER | Medical Electronic Systems, LLC | 2002-09-20 |
| K012805 | AUTOMARQER | Hamilton Thorne Research | 2002-03-13 |
| K012352 | SQA, SPERM QUALITY ANALYZER | Medical Electronic Systems, LLC | 2001-09-21 |
| K011679 | FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY | Embryotech Laboratories, Inc. | 2001-08-15 |
| K990184 | AUTOMARQER | Hamilton Thorne Research | 1999-03-19 |
| K983473 | FERTILMARQ TEST KIT | Embryotech Laboratories, Inc. | 1998-12-17 |
| K915229 | SEMEN ANALYSIS KIT | Humagen Fertility Diagnostics, Inc. | 1994-08-30 |
| K894949 | SQA | United Medical Systems, Inc. | 1989-12-29 |
| K881765 | CTS-3060 AUTOMATED SEMEN ANALYZER | Motion Analysis Corp. | 1989-02-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 14719874742680 | LensHooke Semen Quality Analyzer | BONRAYBIO CO., LTD. | 2026-04-23 |
| 00859500005288 | FemSperm Analyzer | FEMASYS INC. | 2026-02-06 |
| 14719874743571 | LensHooke Sperm DNA fragmentation rapid test kit (SCD assay) | BONRAYBIO CO., LTD. | 2026-02-06 |
| 14719874743533 | LensHooke Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay) | BONRAYBIO CO., LTD. | 2026-02-06 |
| 14719874743526 | LensHooke Sperm Double Strand DNA fragmentation Rapid Test Kit (SDFR Assay) | BONRAYBIO CO., LTD. | 2026-02-06 |
| 14719874743519 | LensHooke Semen Test Slide | BONRAYBIO CO., LTD. | 2026-02-06 |
| 14719874743502 | LensHooke Semen Test Slide | BONRAYBIO CO., LTD. | 2026-02-06 |
| 00859500005349 | FemSperm Pack Analysis | FEMASYS INC. | 2026-02-06 |
| 00859500005318 | FemSperm Pack Analysis | FEMASYS INC. | 2026-02-06 |
| 14719874743564 | LensHooke Sperm DNA fragmentation rapid test kit (SCD assay) | BONRAYBIO CO., LTD. | 2026-02-06 |
| 20888937025846 | HBA® | Coopersurgical, Inc. | 2025-10-20 |
| 14719874743465 | LensHooke Semen Analysis System | BONRAYBIO CO., LTD. | 2025-09-01 |
| 14719874743458 | LensHooke Semen Analysis System | BONRAYBIO CO., LTD. | 2025-09-01 |
| 07290016650822 | SQA-iOw Sperm Quality Analyzer | M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD. | 2025-05-21 |
| 14719874743069 | LensHooke Cleaning Wipe | BONRAYBIO CO., LTD. | 2025-02-16 |
| 14719874740808 | LensHooke Cleaning Wipe | BONRAYBIO CO., LTD. | 2025-02-16 |
| 14719874740747 | LensHooke Cleaning Wipe | BONRAYBIO CO., LTD. | 2025-02-16 |
| 04719874741303 | LensHooke Semen Quality Analyzer | BONRAYBIO CO., LTD. | 2025-02-16 |
| 07290016650754 | YO Home Sperm Test | M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD. | 2025-01-16 |
| 07290016650792 | YO Home Sperm Test | M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD. | 2025-01-16 |
| 07290016650785 | YO Home Sperm Test | M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD. | 2025-01-16 |
| 07290016650778 | YO Home Sperm Test | M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD. | 2025-01-16 |
| 07290016650761 | YO Home Sperm Test | M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD. | 2025-01-16 |
| 07290016650587 | YO Home Sperm Test | M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD. | 2023-01-01 |
| 14719874740716 | LensHooke Semen Test Cassette | BONRAYBIO CO., LTD. | 2019-10-07 |
| 00805360018401 | Spermac Stain | VITROLIFE INC. | 2018-04-23 |
| 00805360018395 | Spermac Stain | VITROLIFE INC. | 2018-04-23 |
| 00805360018418 | Spermac Stain - Fixative | VITROLIFE INC. | 2018-04-23 |
| 00805360018425 | Spermac Stain - Fixative | VITROLIFE INC. | 2018-04-23 |
| 00805360018470 | Vitalscreen | VITROLIFE INC. | 2018-04-23 |