DeviceClearance

Product code PKP— General Hospital

SCIg60 Infusion System

Classification name
Immunoglobulin G (Igg) Infusion System
Device class
Class 2
Regulation
21 CFR 880.5725
Advisory panel
General Hospital
Total cleared
7
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code PKP under 21 CFR 880.5725, via openFDA

Market context for product code PKP

FDA has cleared 7 devices under product code PKP between 2015 and 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PKP

Recent clearances under product code PKP

Data sourced from openFDA. This site is unofficial and independent of the FDA.