DeviceClearance

Product code POV— Hematology

AUTOMARQER

Classification name
Semen Analysis Device
Device class
Class 2
Regulation
21 CFR 864.5220
Advisory panel
Hematology
Total cleared
28
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code POV under 21 CFR 864.5220, via openFDA

Market context for product code POV

FDA has cleared 28 devices under product code POV between 1989 and 2026, filed by 16 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code POV

Recent clearances under product code POV

Data sourced from openFDA. This site is unofficial and independent of the FDA.