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PKP — Immunoglobulin G (Igg) Infusion System Class II

FDA Device Classification

Classification Details

Product Code
PKP
Device Class
Class II
Regulation Number
880.5725
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Definition

An Immunoglobulin G (IgG) Infusion System is a prescription device intended for subcutaneous delivery of Immunoglobulin G (IgG) in accordance with the FDA approved labeling.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251105emed technologies corporationTetra (TM-20); Tetra (TM-50)December 22, 2025
K240148emed technologies corporationSCIg60 Infusion SystemFebruary 16, 2024
K230883emed technologies corporationVersaPump Infusion SystemNovember 28, 2023
K222087emed technologies corporationSCIg60 Infusion SystemOctober 13, 2022
K173783emed technologies corporationSCIg60 Infusion SystemDecember 14, 2018
K161906emed technologies corporationSCIg60 InfuserDecember 1, 2016
K142319emed technologies corporationSCIg60 Infuser, InfusetMay 14, 2015