FDA 510(k) Applications for Medical Device Product Code "POV"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K032874 | BIOCOAT, INC. | HBA SPERM-HYALURONAN BINDING ASSAY | 11/24/2003 |
| K024337 | BIOSHAF LTD. | GENERAL SEMEN ANALYSIS (GSA) KIT | 07/03/2003 |
| K202089 | Bonraybio Co., Ltd. | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer | 10/28/2020 |
| K180343 | Bonraybio Co., Ltd. | LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer | 11/16/2018 |
| K242388 | Bonraybio Co., LTD. | LensHooke X12 PRO Semen Analysis System | 05/09/2025 |
| K242830 | Bonraybio Co., LTD. | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer | 05/30/2025 |
| K071737 | DYN-BIOSHAF (2006) LTD. | GENERAL SEMEN ANALYSIS KIT | 10/25/2007 |
| K011679 | EMBRYOTECH LABORATORIES, INC. | FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY | 08/15/2001 |
| K983473 | EMBRYOTECH LABORATORIES, INC. | FERTILMARQ TEST KIT | 12/17/1998 |
| K041039 | GENOSIS LTD. | FERTELL MALE FERTILITY TEST | 07/20/2004 |
| K012805 | HAMILTON THORNE RESEARCH | AUTOMARQER | 03/13/2002 |
| K990184 | HAMILTON THORNE RESEARCH | AUTOMARQER | 03/19/1999 |
| K220828 | Medical Electronic Systems LTD | SQA-iO Sperm Quality Analyzer | 08/07/2023 |
| K063864 | MEDICAL ELECTRONIC SYSTEMS LTD. | QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS | 03/26/2007 |
| K243114 | Medical Electronic Systems Ltd. | SQA-iOw Sperm Quality Analyzer | 05/02/2025 |
| K241628 | Medical Electronic Systems Ltd. | YO Home Sperm Test | 11/29/2024 |
| K021746 | MEDICAL ELECTRONIC SYSTEMS, LLC | SQA V, SPERM QUALITY ANALYZER | 09/20/2002 |
| K012352 | MEDICAL ELECTRONIC SYSTEMS, LLC | SQA, SPERM QUALITY ANALYZER | 09/21/2001 |
| K161493 | MEDICAL ELECTRONIC SYSTEMS, LTD | YO Home Sperm Test | 11/08/2016 |
| K183602 | MotilityCount ApS | SwimCount Sperm Quality Test | 06/27/2019 |
| K100341 | PRINCETON BIOMEDITECH CORP. | SPERMCHECK FERTILITY | 05/04/2010 |
| K073039 | PRINCETON BIOMEDITECH CORP. | SPERMCHECK VASECTOMY | 01/24/2008 |
| K153683 | SANDSTONE DIAGNOSTICS, INC. | Trak Male Fertility Testing System | 05/16/2016 |
| K172514 | Sandstone Diagnostics, Inc. | Trak Plus Male Fertility Testing System | 11/17/2017 |
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