Clearance Summary
FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing received FDA 510(k) clearance under submission number K252015, sponsored by Koru Medical Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2026-01-28.
- Submission: K252015
- Applicant / Sponsor: Koru Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2026-01-28
Classification & Regulation
This clearance is catalogued under FDA product code FRN and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.