COMPANY
KORU Medical Systems
Timeline
- FDA FDA 510(k) clearance: FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing — K252015, Jan 28, 2026. Applicant at approval: Koru Medical Systems, Inc. source ↗
- Trial start Not phased (device or behavioral study): Assessing Patient Preference for Infusion Systems source ↗
Clinical trials (lead sponsor) 1
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT07189013 | Assessing Patient Preference for Infusion Systems | Not phased (device or behavioral study) | Not yet recruiting | Oct 15, 2025 | 2026-03 (estimated) |
FDA records (last 2 years)
- FDA 510(k) clearance: FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing — K252015, Jan 28, 2026. Applicant at approval: Koru Medical Systems, Inc. source ↗
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