# K162613: Integrated Catch-up Freedom Syringe Driver Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Repro-Med Systems, Inc. Dba Rms Medical Products
- Decided: Aug 31, 2017 after 346 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: 1 generation back to K933652 (1994). 1 ancestor in all.
6 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933652: Freedom 60 Syringe Infusion Pump System with Syringe Set & Tubing, Repro-Med Systems, Inc. (1994) Summary page 4.

## Most influential descendants
- K200176: FREEDOM Integrated Syringe Infusion System (2021), 2 descendants of its own
- K211206: FreedomEdge (R) Syringe Infusion System (2021), 2 descendants of its own
- 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
- K232328: Insignis™ Syringe Infusion System (2024), 0 descendants of its own

## Indications for use
The Integrated Catch-Up Freedom Syringe Driver Infusion System (ICFSDIS), which includes the FREEDOM60® and FreedomEdge® syringe pumps, 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 ICFSDIS is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling: Hizentra, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring); Gammagard Liquid, Immune Globulin Infusion (Human) 10% (manufactured by Shire); and Cuvitru Immune Globulin Infusion (Human) 20% (manufactured by Shire). The ICFSDIS is specifically indicated for the intravenous infusion of the following antibiotics when used according to the FDA approved drug product labeling: meropenem, ertapenem, oxacillin, and tobramycin. The FreedomEdge® Syringe Infusion System is indicated for use with the BD 20 ml (model no. 302830/301031) or BD 30 ml (model no. 301033) syringe. The Freedom60 Syringe Infusion System is indicated for use with the BD 60 ml syringe (model no. 309653).

Source page: https://510kreport.com/device/K162613
Methodology: https://510kreport.com/methodology