Clearance Summary
SQA-iOw Sperm Quality Analyzer received FDA 510(k) clearance under submission number K243114, sponsored by Medical Electronic Systems , Ltd.. The device was reviewed via the Dual Track premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2025-05-02.
- Submission: K243114
- Applicant / Sponsor: Medical Electronic Systems , Ltd.
- Clearance pathway: Dual Track
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5220
- Decision date: 2025-05-02
Classification & Regulation
This clearance is catalogued under FDA product code POV and 21 CFR 864.5220, within the Hematology review panel as a Class II device.