PKP — Immunoglobulin G (Igg) Infusion System Class II
FDA product code PKP covers "Immunoglobulin G (Igg) Infusion System", a Class II medical device regulated under 21 CFR 880.5725. Submissions are reviewed by the General Hospital panel. At least 7 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251105 | emed technologies corporation | Tetra (TM-20); Tetra (TM-50) | December 22, 2025 |
| K240148 | emed technologies corporation | SCIg60 Infusion System | February 16, 2024 |
| K230883 | emed technologies corporation | VersaPump Infusion System | November 28, 2023 |
| K222087 | emed technologies corporation | SCIg60 Infusion System | October 13, 2022 |
| K173783 | emed technologies corporation | SCIg60 Infusion System | December 14, 2018 |
| K161906 | emed technologies corporation | SCIg60 Infuser | December 1, 2016 |
| K142319 | emed technologies corporation | SCIg60 Infuser, Infuset | May 14, 2015 |