# K252015: FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing

- Pathway: 510(k) (Traditional)
- Applicant: Koru Medical Systems, Inc.
- Decided: Jan 28, 2026 after 215 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: 4 generations back to K933652 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K214045: FreedomEdge Syringe Infusion System, Repro-Medical System, Inc., Dba Koru Medical Systems (2022) Summary page 6.

## Indications for use
The FreedomEdge® Syringe Infusion System consists of the following components: • FreedomEdge® Infusion Pump • Precision Flow Rate Tubing™ • High-Flo SubQ Needle Sets™ 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 FreedomEdge Infusion System is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins in the home, hospital, or ambulatory settings when administered 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®) • Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid 20ml Single-use pre-filled syringe (manufactured by CSL Behring®) For EMPAVELI™ (pegcetacoplan) Administration: The FreedomEdge Infusion System is specifically indicated for the subcutaneous infusion of EMPAVELI™ (pegcetacoplan) in the home, hospital, or ambulatory setting when administered according to the approved drug product labeling. For RYSTIGGO® (rozanolixizumab-noli) Administration: The FreedomEdge Infusion System is specifically indicated for the subcutaneous infusion of RYSTIGGO® (rozanolixizumab-noli) when administered according to the approved drug product labeling. For Intravenous Antibiotic Administration: The FreedomEdge Infusion Pump and Precision Flow Rate Tubing are 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/K252015
Methodology: https://510kreport.com/methodology