K252015
- 510(k) number
- K252015
- Device name
- FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing
- Applicant
- Koru Medical Systems, Inc. NJ · US
- Product code
- FRN — Pump, Infusion
- Decision date
- 2026-01-28
- Date received
- 2025-06-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252015.pdf
Official FDA record: K252015
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.