POV

Semen Analysis Device

Product code

POV

Device name

Semen Analysis Device

Device class

Class 2

21 CFR

21 CFR 864.5220

Medical specialty

Hematology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

5

Summaries archived here

5 (direct download)

510(k) clearances (all years, FDA)

28 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (5)

Last three years. Most recent: 2026-04-09.

5 summaries are archived here for direct download.