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FDA 510(k)

FREEDOM Integrated Syringe Infusion System

K-Number: K200176 · 2021-12-15

ApplicantRepro-Med Systems, Inc. Dba Koru Medical Systems
Decision Date2021-12-15
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FREEDOM Integrated Syringe Infusion System is the device name listed in this FDA 510(k) record. The listed applicant is Repro-Med Systems, Inc. Dba Koru Medical Systems. It received FDA 510(k) clearance on 2021-12-15 under 510(k) number K200176. 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 FREEDOM Integrated Syringe Infusion System?

FREEDOM Integrated Syringe Infusion System is a medical device that received FDA 510(k) clearance on 2021-12-15. The listed applicant is Repro-Med Systems, Inc. Dba Koru Medical Systems. The 510(k) number is K200176.

When did FREEDOM Integrated Syringe Infusion System receive FDA 510(k) clearance?

FREEDOM Integrated Syringe Infusion System received FDA 510(k) clearance on 2021-12-15, under 510(k) number K200176.

Who is the listed applicant for FREEDOM Integrated Syringe Infusion System?

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

What is the FDA product code for FREEDOM Integrated Syringe Infusion System?

The FDA product code for FREEDOM Integrated Syringe Infusion System 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

Related Devices (Code: FRN)

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.

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpK252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed CorporationK243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc.

Official Source

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

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