K220828 is an FDA 510(k) clearance for the SQA-iO Sperm Quality Analyzer. This device is classified as a Semen Analysis Device (Class II - Special Controls, product code POV).
Submitted by Medical Electronic Systems , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on August 7, 2023, 503 days after receiving the submission on March 22, 2022.
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 | K220828 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 2022 |
| Decision Date | August 07, 2023 |
| Days to Decision | 503 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. |