FDA Product Code POV: Semen Analysis Device
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.
Leading manufacturers include Medical Electronic Systems , Ltd., Bonraybio Co., Ltd. and Embryotech Laboratories, Inc..
28
Total
28
Cleared
193d
Avg days
1989
Since
Growing category -
5 submissions in the last 2 years
vs 1 in the prior period
Review times increasing: avg
236d
recently vs 184d historically
FDA 510(k) Cleared Semen Analysis Device Devices (Product Code POV)
28 devices
Cleared
Apr 09, 2026
Seaman Pro/Seaman
Checkcells, Inc.
Hematology
267d
Cleared
May 30, 2025
LensHooke X3 PRO Semen Quality Analyzer
Bonraybio Co., Ltd.
Hematology
253d
Cleared
May 09, 2025
LensHooke X12 PRO Semen Analysis System
Bonraybio Co., Ltd.
Hematology
270d
Cleared
May 02, 2025
SQA-iOw Sperm Quality Analyzer
Medical Electronic Systems , Ltd.
Hematology
214d
Cleared
Nov 29, 2024
YO Home Sperm Test
Medical Electronic Systems , Ltd.
Hematology
176d
Cleared
Aug 07, 2023
SQA-iO Sperm Quality Analyzer
Medical Electronic Systems , Ltd.
Hematology
503d
Cleared
Oct 28, 2020
LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer
Bonraybio Co., Ltd.
Hematology
92d
Cleared
Jun 27, 2019
SwimCount Sperm Quality Test
Motilitycount Aps
Hematology
183d
Cleared
Nov 16, 2018
LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer
Bonraybio Co., Ltd.
Hematology
282d
Cleared
Nov 17, 2017
Trak Plus Male Fertility Testing System
Sandstone Diagnostics, Inc.
Hematology
88d
Cleared
Nov 08, 2016
YO Home Sperm Test
Medical Electronic Systems , Ltd.
Hematology
160d
Cleared
May 16, 2016
Trak Male Fertility Testing System
Sandstone Diagnostics, Inc.
Hematology
146d
Cleared
May 04, 2010
SPERMCHECK FERTILITY
Princeton BioMeditech Corp.
Hematology
88d
Cleared
Jan 24, 2008
SPERMCHECK VASECTOMY
Princeton BioMeditech Corp.
Hematology
87d
Cleared
Oct 25, 2007
GENERAL SEMEN ANALYSIS KIT
Dyn-Bioshaf (2006) , Ltd.
Hematology
121d
Cleared
Mar 26, 2007
QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS
Medical Electronic Systems , Ltd.
Hematology
87d
Cleared
Sep 20, 2002
SQA V, SPERM QUALITY ANALYZER
Medical Electronic Systems, LLC
Hematology
115d
Cleared
Mar 13, 2002
AUTOMARQER
Hamilton Thorne Research
Hematology
204d
Cleared
Sep 21, 2001
SQA, SPERM QUALITY ANALYZER
Medical Electronic Systems, LLC
Hematology
58d
Cleared
Aug 15, 2001
FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY
Embryotech Laboratories, Inc.
Hematology
77d
Cleared
Mar 19, 1999
AUTOMARQER
Hamilton Thorne Research
Hematology
58d
Cleared
Dec 17, 1998
FERTILMARQ TEST KIT
Embryotech Laboratories, Inc.
Hematology
76d
About Product Code POV - Regulatory Context
510(k) Submission Activity
28 total 510(k) submissions under product code POV since 1989, with 28 receiving FDA clearance (average review time: 193 days).
Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - POV Product Code
Recent submissions under POV have taken an average of 236 days to reach a decision - up from 184 days historically. Manufacturers should account for longer review timelines in current project planning.
POV devices are reviewed by the Hematology panel. Browse all Hematology devices →