Semen Analysis Device
The Semen Analysis Device (product code POV) is a Class 2 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, regulated under 864.5220. It requires 510(k) clearance. The device is not an implant and is not life-sustaining.
Basic Information
- Product Code
- POV
- Device Class
- FDA class 2
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 27 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K242830 | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer | May 30, 2025 | Substantially Equivalent | Bonraybio Co., LTD. |
| K242388 | LensHooke X12 PRO Semen Analysis System | May 09, 2025 | Substantially Equivalent | Bonraybio Co., LTD. |
| K243114 | SQA-iOw Sperm Quality Analyzer | May 02, 2025 | Substantially Equivalent | Medical Electronic Systems Ltd. |
| K241628 | YO Home Sperm Test | Nov 29, 2024 | Substantially Equivalent | Medical Electronic Systems Ltd. |
| K220828 | SQA-iO Sperm Quality Analyzer | Aug 07, 2023 | Substantially Equivalent | Medical Electronic Systems LTD |
| K202089 | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer | Oct 28, 2020 | Substantially Equivalent | Bonraybio Co., Ltd. |
| K183602 | SwimCount Sperm Quality Test | Jun 27, 2019 | Substantially Equivalent | MotilityCount ApS |
| K180343 | LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer | Nov 16, 2018 | Substantially Equivalent | Bonraybio Co., Ltd. |
| K172514 | Trak Plus Male Fertility Testing System | Nov 17, 2017 | Substantially Equivalent | Sandstone Diagnostics, Inc. |
| K161493 | YO Home Sperm Test | Nov 08, 2016 | Substantially Equivalent | MEDICAL ELECTRONIC SYSTEMS, LTD |
| K153683 | Trak Male Fertility Testing System | May 16, 2016 | Substantially Equivalent | SANDSTONE DIAGNOSTICS, INC. |
| K100341 | SPERMCHECK FERTILITY | May 04, 2010 | Substantially Equivalent | PRINCETON BIOMEDITECH CORP. |
| K073039 | SPERMCHECK VASECTOMY | Jan 24, 2008 | Substantially Equivalent | PRINCETON BIOMEDITECH CORP. |
| K071737 | GENERAL SEMEN ANALYSIS KIT | Oct 25, 2007 | Substantially Equivalent | DYN-BIOSHAF (2006) LTD. |
| K063864 | QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS | Mar 26, 2007 | Substantially Equivalent | MEDICAL ELECTRONIC SYSTEMS LTD. |
| K041039 | FERTELL MALE FERTILITY TEST | Jul 20, 2004 | Substantially Equivalent | GENOSIS LTD. |
| K032874 | HBA SPERM-HYALURONAN BINDING ASSAY | Nov 24, 2003 | Substantially Equivalent | BIOCOAT, INC. |
| K024337 | GENERAL SEMEN ANALYSIS (GSA) KIT | Jul 03, 2003 | Substantially Equivalent | BIOSHAF LTD. |
| K021746 | SQA V, SPERM QUALITY ANALYZER | Sep 20, 2002 | Substantially Equivalent | MEDICAL ELECTRONIC SYSTEMS, LLC |
| K012805 | AUTOMARQER | Mar 13, 2002 | Substantially Equivalent | HAMILTON THORNE RESEARCH |
| K012352 | SQA, SPERM QUALITY ANALYZER | Sep 21, 2001 | Substantially Equivalent | MEDICAL ELECTRONIC SYSTEMS, LLC |
| K011679 | FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY | Aug 15, 2001 | Substantially Equivalent | EMBRYOTECH LABORATORIES, INC. |
| K990184 | AUTOMARQER | Mar 19, 1999 | Substantially Equivalent | HAMILTON THORNE RESEARCH |
| K983473 | FERTILMARQ TEST KIT | Dec 17, 1998 | Substantially Equivalent | EMBRYOTECH LABORATORIES, INC. |
| K915229 | SEMEN ANALYSIS KIT | Aug 30, 1994 | Substantially Equivalent | Humagen FERTILITY DIAGNOSTICS, INC. |
| K894949 | SQA | Dec 29, 1989 | Substantially Equivalent | UNITED MEDICAL SYSTEMS, INC. |
| K881765 | CTS-3060 AUTOMATED SEMEN ANALYZER | Feb 15, 1989 | Substantially Equivalent | MOTION ANALYSIS CORP. |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.