5 devices · 3 companies · 2018 to 2026
Product code POV: Semen Analysis Device
5 devices under product code POV, 2018 to 2026, from 3 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (5 of 5 here), the regulation, and MAUDE report counts by product code.
Semen Analysis Device. 21 CFR 864.5220, Class II. 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. MAUDE held 1 adverse-event report against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Seaman Pro/SeamanK252228 · 510(k) | Checkcells, Inc. | Hematology | database entry | |
| LensHooke X3 PRO Semen Quality AnalyzerK242830 · 510(k) | Bonraybio Co., LTD. | Hematology | database entry | |
| LensHooke X12 PRO Semen Analysis SystemK242388 · 510(k) | Bonraybio Co., LTD. | Hematology | database entry | |
| LensHooke X1 PRO Semen Quality Analyzer, LensHooK202089 · 510(k) | Bonraybio Co., Ltd. | Hematology | database entry | |
| LensHooke X1 Pro Semen Quality Analyzer, LensHooK180343 · 510(k) | Bonraybio Co., Ltd. | Hematology | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.