| Seaman Pro/Seaman (K252228) | Checkcells, Inc. | 2026-04-09 |
| LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer (K242830) | Bonraybio Co., Ltd. | 2025-05-30 |
| LensHooke X12 PRO Semen Analysis System (K242388) | Bonraybio Co., Ltd. | 2025-05-09 |
| SQA-iOw Sperm Quality Analyzer (K243114) | Medical Electronic Systems , Ltd. | 2025-05-02 |
| YO Home Sperm Test (K241628) | Medical Electronic Systems , Ltd. | 2024-11-29 |
| SQA-iO Sperm Quality Analyzer (K220828) | Medical Electronic Systems , Ltd. | 2023-08-07 |
| LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer (K202089) | Bonraybio Co., Ltd. | 2020-10-28 |
| SwimCount Sperm Quality Test (K183602) | Motilitycount Aps | 2019-06-27 |
| LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer (K180343) | Bonraybio Co., Ltd. | 2018-11-16 |
| Trak Plus Male Fertility Testing System (K172514) | Sandstone Diagnostics, Inc. | 2017-11-17 |
| YO Home Sperm Test (K161493) | Medical Electronic Systems , Ltd. | 2016-11-08 |
| Trak Male Fertility Testing System (K153683) | Sandstone Diagnostics, Inc. | 2016-05-16 |
| SPERMCHECK FERTILITY (K100341) | Princeton BioMeditech Corp. | 2010-05-04 |
| SPERMCHECK VASECTOMY (K073039) | Princeton BioMeditech Corp. | 2008-01-24 |
| GENERAL SEMEN ANALYSIS KIT (K071737) | Dyn-Bioshaf (2006) , Ltd. | 2007-10-25 |
| QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS (K063864) | Medical Electronic Systems , Ltd. | 2007-03-26 |
| FERTELL MALE FERTILITY TEST (K041039) | Genosis , Ltd. | 2004-07-20 |
| HBA SPERM-HYALURONAN BINDING ASSAY (K032874) | Biocoat, Inc. | 2003-11-24 |
| GENERAL SEMEN ANALYSIS (GSA) KIT (K024337) | Bioshaf , Ltd. | 2003-07-03 |
| SQA V, SPERM QUALITY ANALYZER (K021746) | Medical Electronic Systems, LLC | 2002-09-20 |
| AUTOMARQER (K012805) | Hamilton Thorne Research | 2002-03-13 |
| SQA, SPERM QUALITY ANALYZER (K012352) | Medical Electronic Systems, LLC | 2001-09-21 |
| FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY (K011679) | Embryotech Laboratories, Inc. | 2001-08-15 |
| AUTOMARQER (K990184) | Hamilton Thorne Research | 1999-03-19 |
| FERTILMARQ TEST KIT (K983473) | Embryotech Laboratories, Inc. | 1998-12-17 |
| SEMEN ANALYSIS KIT (K915229) | Humagen Fertility Diagnostics, Inc. | 1994-08-30 |
| SQA (K894949) | United Medical Systems, Inc. | 1989-12-29 |
| CTS-3060 AUTOMATED SEMEN ANALYZER (K881765) | Motion Analysis Corp. | 1989-02-15 |