Koru Medical Systems, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 2
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252015 | FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing | January 28, 2026 |
| K231918 | Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Sup | November 3, 2023 |