Clearance Summary
Edema Guard Monitor (EGM) CardioSet-001 received FDA 510(k) clearance under submission number K250922, sponsored by Cardioset Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2025-09-09.
- Submission: K250922
- Applicant / Sponsor: Cardioset Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2770
- Decision date: 2025-09-09
Classification & Regulation
This clearance is catalogued under FDA product code DSB and 21 CFR 870.2770, within the Cardiovascular review panel as a Class II device.