Clearance Summary
CHLOE BLAST received FDA 510(k) clearance under submission number K243851, sponsored by Fairtility , Ltd.. 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 2025-08-15.
- Submission: K243851
- Applicant / Sponsor: Fairtility , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6195
- Decision date: 2025-08-15
Classification & Regulation
This clearance is catalogued under FDA product code PBH and 21 CFR 884.6195, within the Obstetrics/Gynecology review panel as a Class II device.