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 Checkcells, Inc..
FDA 510(k) Cleared Semen Analysis Device Devices (Product Code POV)
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 Review Time
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 →