K161493 is an FDA 510(k) clearance for the YO Home Sperm Test. This device is classified as a Semen Analysis Device (Class II - Special Controls, product code POV).
Submitted by Medical Electronic Systems , Ltd. (Caesarea Ind. Park, IL). The FDA issued a Cleared decision on November 8, 2016, 160 days after receiving the submission on June 1, 2016.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220. 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..
| 510(k) Number | K161493 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2016 |
| Decision Date | November 08, 2016 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | POV - Semen Analysis Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5220 |
| 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. |