Immunoglobulin G (Igg) Infusion System
The Immunoglobulin G (IgG) Infusion System (product code PKP) is a Class 2 general hospital prescription device intended for subcutaneous delivery of IgG in accordance with FDA-approved labeling, regulated under 880.5725. It requires 510(k) clearance and falls within the General Hospital medical specialty. The device is not flagged as an implant or life-sustaining product.
Research product code PKP in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- PKP
- Device Class
- FDA class 2
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251105 | Tetra (TM-20); Tetra (TM-50) | Dec 22, 2025 | Substantially Equivalent | Emed Technologies Corporation |
| K240148 | SCIg60 Infusion System | Feb 16, 2024 | Substantially Equivalent | Emed Technologies Corporation |
| K230883 | VersaPump Infusion System | Nov 28, 2023 | Substantially Equivalent | Emed Technologies Corporation |
| K222087 | SCIg60 Infusion System | Oct 13, 2022 | Substantially Equivalent | Emed Technologies Corporation |
| K173783 | SCIg60 Infusion System | Dec 14, 2018 | Substantially Equivalent | Emed Technologies Corporation |
| K161906 | SCIg60 Infuser | Dec 01, 2016 | Substantially Equivalent | Emed Technologies Corporation |
| K142319 | SCIg60 Infuser, Infuset | May 14, 2015 | Substantially Equivalent | Emed Technologies Corporation |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.