← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
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.
DEVICE CLASS
Class II
REGULATION
21 CFR 864.5220
MEDICAL SPECIALTY
Hematology
REVIEW PANEL
HE
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
5
510(K)/PMA CLEARANCES
510k: 5
0
RECALL ENTRIES
Recent clearances
K252228Checkcells, Inc. · 510k2026-04-09
K242830Bonraybio Co., Ltd. · 510k2025-05-30
K242388Bonraybio Co., Ltd. · 510k2025-05-09
K243114Medical Electronic Systems , Ltd. · 510k2025-05-02
K241628Medical Electronic Systems , Ltd. · 510k2024-11-29
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.