FDA Product Code PKP: Immunoglobulin G (igg) Infusion System
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.
Leading manufacturers include Emed Technologies Corporation.
FDA 510(k) Cleared Immunoglobulin G (igg) Infusion System Devices (Product Code PKP)
About Product Code PKP - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code PKP since 2015, with 7 receiving FDA clearance (average review time: 199 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.
FDA Review Time
Recent submissions under PKP have taken an average of 255 days to reach a decision - up from 189 days historically. Manufacturers should account for longer review timelines in current project planning.
PKP devices are reviewed by the General Hospital panel. Browse all General Hospital devices →