Clearance Summary
SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) received FDA 510(k) clearance under submission number K241348, sponsored by Motilitycount Aps. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2025-01-31.
- Submission: K241348
- Applicant / Sponsor: Motilitycount Aps
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6160
- Decision date: 2025-01-31
Classification & Regulation
This clearance is catalogued under FDA product code MQK and 21 CFR 884.6160, within the Obstetrics/Gynecology review panel as a Class II device.