# K222087: SCIg60 Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Emed Technologies Corporation
- Decided: Oct 13, 2022 after 90 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: 6 generations back to K831445 (1983). 9 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161906: SCIg60 Infuser, Emed Technologies Corporation (2016) Summary page 4.

## Most influential descendants
- K240148: SCIg60 Infusion System (2024), 1 descendant of its own
- K251105: Tetra (TM-20); Tetra (TM-50) (2025), 0 descendants of its own
- K230883: VersaPump Infusion System (2023), 0 descendants of its own

## Indications for use
The SCIg60 Infusion System is intended for the subcutaneous infusion of the following immunoglobulin liquid medications: * Hizentra, Immune Globulin Subcutaneous (Human) 20% (manufactured by CSL Behring), » Gammagard Liquid, Immune Globulin Infusion (Human) 10% (manufactured by Takeda Pharmaceutical Company, formerly Baxalta), * Cuvitru Immune Globulin Infusion (Human) 20% (manufactured by Takeda Pharmaceutical Company, formerly Baxalta) * Gamunex-C Immune Globulin Subcutaneous (Human), 10% (manufactured by Grifols Therapeutics, Inc.), » Gammaked Immune Globulin Subcutaneous (Human), 10% (manufactured by Grifols Therapeutics, Inc.) » Xembify Immune Globulin Subcutaneous (Human), 20% (manufactured by Grifols Therapeutics, Inc.), and * Cutaquig Immune Globulin Subcutaneous (Human), 16.5% (manufactured by Octapharma AG) with the BD 50 ml syringe (model no. 309653) in the home or hospital environment.

Source page: https://510kreport.com/device/K222087
Methodology: https://510kreport.com/methodology