510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PKPClass II

Immunoglobulin G (Igg) Infusion System

21 CFR 880.5725 / General Hospital
FDA source (opens on fda.gov)

PKP is the FDA product code for Immunoglobulin G (Igg) Infusion System, a class II device type, regulated under 21 CFR 880.5725. FDA's definition for this code reads: "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". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PKP
Device name
Immunoglobulin G (Igg) Infusion System
FDA 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.
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
0

Clearances, product code PKP

By decision year
7 clearances under product code PKP with a decision year between 2015 and 2025, 2015 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PKP by decision year
YearClearances
20151
20161
20181
20221
20231
20241
20251

Applicants with the most clearances

Product code PKP
Applicants holding the most 510(k) clearances under product code PKP
ApplicantClearances
Emed Technologies Corporation7

Companies listing this code with FDA

Companies whose registered establishments list this code