FDA product code PKP: Immunoglobulin G (Igg) Infusion System
PKP is the FDA product code for immunoglobulin g (igg) infusion system. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the General Hospital panel. FDA has cleared 7 510(k) submissions under PKP, 4 in the last five years. The average 510(k) review took 199 days (median 243); 142 days on average over the last three years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Immunoglobulin G (Igg) Infusion System |
| Device class | Class II |
| Regulation | 21 CFR 880.5725 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for PKP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 366 |
| 2022 | 1 | 90 |
| 2023 | 1 | 243 |
| 2024 | 1 | 28 |
| 2025 | 1 | 255 |
Compare with all 510(k) review times · Search every PKP clearance
Top PKP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Emed Technologies Corporation | 7 | 2025-12-22 |
Most recent PKP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251105 | Emed Technologies Corporation | Tetra (TM-20); Tetra (TM-50) | 2025-12-22 | 255 |
| K240148 | Emed Technologies Corporation | SCIg60 Infusion System | 2024-02-16 | 28 |
| K230883 | Emed Technologies Corporation | VersaPump Infusion System | 2023-11-28 | 243 |
| K222087 | Emed Technologies Corporation | SCIg60 Infusion System | 2022-10-13 | 90 |
| K173783 | Emed Technologies Corporation | SCIg60 Infusion System | 2018-12-14 | 366 |
Recalls for PKP devices
openFDA lists no recalls for product code PKP.
Frequently asked questions
What is FDA product code PKP?
PKP is the FDA product code for immunoglobulin g (igg) infusion system. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the General Hospital panel.
What device class is PKP?
Class II, regulation 21 CFR 880.5725. Typical premarket route: 510(k).
How long does a 510(k) take for product code PKP?
Across 7 cleared submissions the average was 199 days from receipt to decision (median 243).
Which companies have the most PKP clearances?
Emed Technologies Corporation (7).
Next steps
- Run an FDA pathway report with predicate devices for product code PKP
- Run a recall and safety report across every PKP manufacturer
- Watch product code PKP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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