FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing
FDA 510(k) K252015 · Koru Medical Systems, Inc.
510(k) numberK252015
Submission
- Device name
- FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing
- Applicant
- Koru Medical Systems, Inc.
Mahwah, NJ, US - Received
- June 27, 2025
- Decision date
- January 28, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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More from Belmont Medical Technologies
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| K231918 | Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing…FRN · Traditional | 11/03/2023SE |
Questions and answers
When was FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing cleared by the FDA?
FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing (K252015) received a 510(k) decision of Substantially Equivalent on January 28, 2026, 215 days after the submission was received.
What is the product code of K252015?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.