Semen Analysis Device
FDA product code POV · Class II (moderate risk) · 21 CFR 864.5220 · Hematology
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.
28510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Medical Electronic Systems , Ltd. 7
- Bonraybio Co., Ltd. 4
- Embryotech Laboratories, Inc. 2
- Hamilton Thorne Research 2
- Princeton BioMeditech Corp. 2
- Sandstone Diagnostics, Inc. 2
- Motion Analysis Corp. 1
- United Medical Systems, Inc. 1
- Humagen Fertility Diagnostics, Inc. 1
- Bioshaf , Ltd. 1
- Biocoat, Inc. 1
- Genosis , Ltd. 1
- Dyn-Bioshaf (2006) , Ltd. 1
- Motilitycount Aps 1
- Checkcells, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252228 | Seaman Pro/SeamanPOV · Traditional | Checkcells, Inc. | 04/09/2026SE |
| K242830 | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality AnalyzerPOV · Traditional | Bonraybio Co., Ltd. | 05/30/2025SE |
| K242388 | LensHooke X12 PRO Semen Analysis SystemPOV · Traditional | Bonraybio Co., Ltd. | 05/09/2025SE |
| K243114 | SQA-iOw Sperm Quality AnalyzerPOV · Dual Track | Medical Electronic Systems , Ltd. | 05/02/2025SE |
| K241628 | YO Home Sperm TestPOV · Traditional | Medical Electronic Systems , Ltd. | 11/29/2024SE |
| K220828 | SQA-iO Sperm Quality AnalyzerPOV · Traditional | Medical Electronic Systems , Ltd. | 08/07/2023SE |
| K202089 | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality AnalyzerPOV · Special | Bonraybio Co., Ltd. | 10/28/2020SE |
| K183602 | SwimCount Sperm Quality TestPOV · Traditional | Motilitycount Aps | 06/27/2019SE |
| K180343 | LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality AnalyzerPOV · Traditional | Bonraybio Co., Ltd. | 11/16/2018SE |
| K172514 | Trak Plus Male Fertility Testing SystemPOV · Traditional | Sandstone Diagnostics, Inc. | 11/17/2017SE |
| K161493 | YO Home Sperm TestPOV · Traditional | Medical Electronic Systems , Ltd. | 11/08/2016SE |
| K153683 | Trak Male Fertility Testing SystemPOV · Traditional | Sandstone Diagnostics, Inc. | 05/16/2016SE |
| K100341 | Spermcheck FertilityPOV · Traditional | Princeton BioMeditech Corp. | 05/04/2010SE |
| K073039 | Spermcheck VasectomyPOV · Traditional | Princeton BioMeditech Corp. | 01/24/2008SE |
| K071737 | General Semen Analysis KitPOV · Traditional | Dyn-Bioshaf (2006) , Ltd. | 10/25/2007SE |
| K063864 | Qwikcheck Test Strips- Reagent Strips for Semen AnalysisPOV · Traditional | Medical Electronic Systems , Ltd. | 03/26/2007SE |
| K041039 | Fertell Male Fertility TestPOV · Traditional | Genosis , Ltd. | 07/20/2004SE |
| K032874 | Hba Sperm-Hyaluronan Binding AssayPOV · Traditional | Biocoat, Inc. | 11/24/2003SE |
| K024337 | General Semen Analysis (Gsa) KitPOV · Traditional | Bioshaf , Ltd. | 07/03/2003SE |
| K021746 | Sqa V, Sperm Quality AnalyzerPOV · Traditional | Medical Electronic Systems, LLC | 09/20/2002SE |
| K012805 | AutomarqerPOV · Traditional | Hamilton Thorne Research | 03/13/2002SE |
| K012352 | Sqa, Sperm Quality AnalyzerPOV · Traditional | Medical Electronic Systems, LLC | 09/21/2001SE |
| K011679 | Fertilmarq Home Diagnostic Screening Test Kit for Male InfertilityPOV · Traditional | Embryotech Laboratories, Inc. | 08/15/2001SE |
| K990184 | AutomarqerPOV · Traditional | Hamilton Thorne Research | 03/19/1999SE |
| K983473 | Fertilmarq Test KitPOV · Traditional | Embryotech Laboratories, Inc. | 12/17/1998SE |
| K915229 | Semen Analysis KitPOV · Traditional | Humagen Fertility Diagnostics, Inc. | 08/30/1994SE |
| K894949 | SqaPOV · Traditional | United Medical Systems, Inc. | 12/29/1989SE |
| K881765 | CTS-3060 Automated Semen AnalyzerPOV · Traditional | Motion Analysis Corp. | 02/15/1989SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0757-2026 Class II | Sperm TestDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0750-2026 Class II | Sperm TestDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |