# K161906: SCIg60 Infuser

- Pathway: 510(k) (Traditional)
- Applicant: Emed Technologies Corporation
- Decided: Dec 1, 2016 after 142 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: 5 generations back to K831445 (1983). 8 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142319: SCIg60 Infuser, Infuset, Emed Technologies Corporation (2015) Summary page 4.

## Most influential descendants
- K222087: SCIg60 Infusion System (2022), 3 descendants of its own
- 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
- K173783: SCIg60 Infusion System (2018), 0 descendants of its own

## Indications for use
The SCIg60 Infusion System is intended for use in the home or hospital environment for the subcutaneous infusion of Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid (manufactured by CSL Behring), Gammagard Liquid, Immune Globulin Infusion (Human) 10% (manufactured by Baxalta), and Cuvitru Immune Globulin Infusion (Human) 20% (manufactured by Baxalta) with the BD 60 ml syringe (model no. 309653).

Source page: https://510kreport.com/device/K161906
Methodology: https://510kreport.com/methodology