Clearance Summary
Deterioration Index Version 2 received FDA 510(k) clearance under submission number K260008, sponsored by Epic Systems Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2026-09-18.
- Submission: K260008
- Applicant / Sponsor: Epic Systems Corporation
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2210
- Decision date: 2026-09-18
Classification & Regulation
This clearance is catalogued under FDA product code QNL and 21 CFR 870.2210, within the Cardiovascular review panel as a Class II device.