FDA 510(k)

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

K-Number: K252015 · 2026-01-28

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 the device name listed in this FDA 510(k) record. The listed applicant is Koru Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-01-28 under 510(k) 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. The listed applicant is Koru Medical Systems, Inc.. The 510(k) number is K252015.

When did FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing receive FDA 510(k) clearance?

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

Who is the listed applicant for FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing?

The FDA 510(k) record lists Koru Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07721350Prospective Evaluation of Subcutaneous Administration of Daratumumab by the FreedomEDGE® Infusion SystemNOT_YET_RECRUITING NCT07670936Effect of Cerebellar Fastigial Nucleus Stimulation Combined With Sling Exercise on Motor Function in Hemiplegic Stroke PatientsNOT_YET_RECRUITING NCT06955793Expanded Access to TAK-881 for People With Primary Immunodeficiency Diseases in the USA and Czech RepublicAVAILABLE NCT07274657Superb Microvascular Imaging (SMI) and Two-Dimensional Endoscopic Ultrasound Guided Shear Wave Elastography (2D-SWE-EUS) in Differential Diagnosis of Pancreatic Adenocarcinoma (PA) From Other Pancreatic Solid Lesions (PSLs) and Pancreatic neuroendocrinE Tumors (pNETs) MalignancyRECRUITING NCT07688863Comparative Effects of Different Inspiratory Muscle Training Modalities in Patients With Heart Failure.ENROLLING_BY_INVITATION

Other records listing Koru Medical Systems, Inc. as applicant

K231918Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter

Related Devices (Code: FRN)

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D Corp K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare Corporation K242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation K243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc.K242115Plum Duo™ Precision IV PumpIcu Medical, Inc.

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.