Clearance Summary
Mcare System (MW-20) received FDA 510(k) clearance under submission number K253673, sponsored by Marani Health, Inc.. 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 2026-09-03.
- Submission: K253673
- Applicant / Sponsor: Marani Health, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2730
- Decision date: 2026-09-03
Classification & Regulation
This clearance is catalogued under FDA product code LQK and 21 CFR 884.2730, within the Obstetrics/Gynecology review panel as a Class II device.