# K214045: FreedomEdge Syringe Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Repro-Medical System, Inc., Dba Koru Medical Systems
- Decided: Apr 29, 2022 after 123 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K933652 (1994). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211206: FreedomEdge (R) Syringe Infusion System, Repro-Medical System, Inc., Dba Koru Medical Systems (2021) Summary page 5.

## Most influential descendants
- K252015: FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing (2026), 0 descendants of its own

## Indications for use
The FreedomEdge® Syringe Infusion System consists of the following components: • FreedomEdge® Syringe Driver • Precision Flow Rate Tubing™ • HIgH-Flo Subcutaneous Safety Needle Sets™ • HIgH-Flo Super26™ Subcutaneous Needle Sets are specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins: Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) Single-use pre-filled syringe for subcutaneous administration. The FreedomEdge® Syringe Infusion System is indicated for use with the BD® 20 ml syringe (US Reference number: 302830), BD 30 ml syringe (US Reference number: 302832) and Hizentra® 20 ml prefilled syringe (NDC 44206-458-96). For Immunoglobulin Administration: The Freedom Integrated Syringe Infusion System is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling: Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Gammagard Liquid®, Immune Globulin Infusion (Human) 10% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) and Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) Single-use pre-filled syringe for subcutaneous administration in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling. For EMPAVELI™ (pegcetacoplan) Administration: The Freedom Integrated Syringe Infusion System is specifically indicated for the subcutaneous infusion with EMPAVELI™ (pegcetacoplan) in the home, hospital, or ambulatory setting when administered according to the approved drug product labeling. For Intravenous Antibiotic Administration: The Freedom Integrated Syringe Infusion System with the FreedomEdge® Syringe Driver and Precision Flow Rate Tubing™, is specifically indicated for the intravenous infusion of the following antibiotics when used according to the FDA approved drug product labeling: Ertapenem, Meropenem, Oxacillin, and Tobramycin.

Source page: https://510kreport.com/device/K214045
Methodology: https://510kreport.com/methodology