Data / Medical devices / Semen Analysis Device
Semen Analysis Device (POV): 10 FDA-registered makers in 5 countries
10 establishments in 5 countries are registered with the FDA to make Semen Analysis Device (product code POV, Class 2, 21 CFR 864.5220). 8 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 28 510(k) clearances under this code, the latest on April 9, 2026, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- POV
- Device class
- 2
- Regulation
- 864.5220
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Israel | 1 |
| Taiwan | 1 |
| Denmark | 1 |
| Costa Rica | 1 |
Makers of Semen Analysis Device
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medical Electronic Systems Ltd. | CAESAREA IND. PARK Haifa, Israel | Exporter to the US, Manufacturer | 7 | May 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| Bonraybio Co., Ltd. | Taichung, Taiwan | Manufacturer | 4 | May 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| MEDTOX Diagnostics, Inc. | Pleasanton, CA, United States | Manufacturer | 2 | November 17, 2017 | 0 | 0 | 0 | api.fda.gov |
| Princeton Biomeditech Corp. | Monmouth Jct, NJ, United States | Manufacturer | 2 | May 4, 2010 | 0 | 0 | 0 | api.fda.gov |
| Princeton BioMeditech Corp. | Plainsboro, NJ, United States | Manufacturer | 2 | May 4, 2010 | 0 | 0 | 0 | api.fda.gov |
| Princeton BioMeditech Corp. | Skillman, NJ, United States | Manufacturer | 2 | May 4, 2010 | 0 | 0 | 0 | api.fda.gov |
| Coopersurgical, Inc. | Trumbull, CT, United States | Manufacturer | 1 | November 24, 2003 | 0 | 0 | 0 | api.fda.gov |
| Motilitycount Aps | Valby Hovedstaden, Denmark | Complaint file establishment, Exporter to the US, Manufacturer | 1 | June 27, 2019 | 0 | 0 | 0 | api.fda.gov |
| Cooper Medical, SRL | La Garita Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keva Inc. | Blaine, WA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.