# K211206: FreedomEdge (R) Syringe Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Repro-Medical System, Inc., Dba Koru Medical Systems
- Decided: Nov 9, 2021 after 201 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: 2 generations back to K933652 (1994). 2 ancestors in all.
2 later devices descend 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)
- K162613: Integrated Catch-up Freedom Syringe Driver Infusion System, Repro-Med Systems, Inc. Dba Rms Medical Products (2017) Summary page 5.

## Most influential descendants
- K214045: FreedomEdge Syringe Infusion System (2022), 1 descendant of its own
- 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 is indicated for the intravenous or subcutaneous infusion of medications and fluids in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling. The FreedomEdge® 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. The FreedomEdge® 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. 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 single-use pre-filled syringe (NDC 442096-458-96).

Source page: https://510kreport.com/device/K211206
Methodology: https://510kreport.com/methodology