# K240148: SCIg60 Infusion System

- Pathway: 510(k) (Special)
- Applicant: Emed Technologies Corporation
- Decided: Feb 16, 2024 after 28 days
- Product code: PKP (Immunoglobulin G (Igg) Infusion System)
- 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: 7 generations back to K831445 (1983). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222087: SCIg60 Infusion System, Emed Technologies Corporation (2022) Summary page 5.

## Most influential descendants
- K251105: Tetra (TM-20); Tetra (TM-50) (2025), 0 descendants of its own

## Indications for use
The SCIg60 Infusion System is intended for the subcutaneous infusion of indicated fluids in the home or hospital environment for adult or pediatric patients (2 years and older) that require subcutaneous infusion of fluid medication prescribed by a healthcare professional. The SCIg60 Infusion System is indicated for the subcutaneous infusion of: • 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%, manufactured by CSL Behring, • Gamunex-C Immune Globulin Subcutaneous (Human) 10%, manufactured by Grifols Therapeutics • Gammaked Immune Globulin Subcutaneous (Human) 10%, manufactured by Grifols Therapeutics • Xembify Immune Globulin Subcutaneous (Human) 20%, manufactured by Grifols Therapeutics, and • Cutaquig Immune Globulin (Human), 16.5%, manufactured by Octapharma AG The SCIg60 Infuser Pump is intended for single patient, multiple use only, while flow controller and patient administration sets are single-use only.

Source page: https://510kreport.com/device/K240148
Methodology: https://510kreport.com/methodology