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FDA 510(k)

FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing

K-Number: K252015 · 2026-01-28

ApplicantKoru Medical Systems, Inc.
Decision Date2026-01-28
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing is a medical device manufactured by Koru Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-01-28 under approval number K252015. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing?

FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing is a medical device that received FDA 510(k) clearance on 2026-01-28. It is manufactured by Koru Medical Systems, Inc.. The 510(k) number is K252015.

When was FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing approved by the FDA?

FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing received FDA 510(k) clearance on 2026-01-28, under approval number K252015.

What company makes FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing?

FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing is manufactured by Koru Medical Systems, Inc..

What is the FDA product code for FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing?

The FDA product code for FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing is FRN.

Related Clinical Trials

NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT04910841 Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine RECRUITING NCT07585812 Comfort-in Needle-Free Injection System in Pediatric Dental Anesthesia COMPLETED NCT07581249 This Study Evaluate the Patient Response to Jet Injection, Pain and Satisfaction Compared to Conventional Method of Local Anasthesia Especially in Maxillary Teeth COMPLETED

Related Devices (Code: FRN)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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