Data / Medical devices / Immunoglobulin G (Igg) Infusion System
Immunoglobulin G (Igg) Infusion System (PKP): 9 FDA-registered makers in 3 countries
9 establishments in 3 countries are registered with the FDA to make Immunoglobulin G (Igg) Infusion System (product code PKP, Class 2, 21 CFR 880.5725). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on December 22, 2025, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PKP
- Device class
- 2
- Regulation
- 880.5725
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Mexico | 2 |
| China | 1 |
Makers of Immunoglobulin G (Igg) Infusion System
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Emed Technologies Corporation | El Dorado Hills, CA, United States | Specification developer | 7 | December 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Tutamen De Mexico, LLC | Tijuana Baja California, Mexico | Manufacturer | 1 | February 16, 2024 | 0 | 0 | 0 | api.fda.gov |
| Cardio Technics S.A. De C.V. | SAN ANDRES CHOLULA Puebla, Mexico | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dimcogray Corp. Dba DG Medical | Centerville, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovative Health Sciences | Chester, NY, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jdi Electronics Factory | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Koru Medical Systems, Inc. | Mahwah, NJ, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PRIDE Industries | Roseville, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Taurus Engineering And Manufacturing, Inc. | Saint Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 22, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.