PKP

Immunoglobulin G (Igg) Infusion System

Product code: PKP
Device name: Immunoglobulin G (Igg) Infusion System
Device class: Class 2
21 CFR: 21 CFR 880.5725
Medical specialty: General Hospital
Marketing pathway: 510(K)
510(k) clearances (last 3 years): 3
Summaries archived here: 3 (direct download)
510(k) clearances (all years, FDA): 7 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2025-12-22.

Number	Decision date	Applicant	Device name	Summary
K251105	2025-12-22	Emed Technologies Corporation	Tetra (TM-20); Tetra (TM-50)	PDF
K240148	2024-02-16	Emed Technologies Corporation	SCIg60 Infusion System	PDF
K230883	2023-11-28	Emed Technologies Corporation	VersaPump Infusion System	PDF

3 summaries are archived here for direct download.

Official FDA classification page: PKP

Classification and pathway per current FDA publications. Data from openFDA (CC0).