PDIHumanitarian device exemption

Beta 2-Microglobulin Apheresis Column

Unknown

PDI is the FDA product code for Beta 2-Microglobulin Apheresis Column. FDA's definition for this code reads: "Relief of symptoms of clinically diagnosed dialysis-related amyloidosis (DRA)". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: PDI
Device name: Beta 2-Microglobulin Apheresis Column
FDA definition: Relief of symptoms of clinically diagnosed dialysis-related amyloidosis (DRA).
Device class: Humanitarian device exemption
Review panel: Unknown
Submission type: FDA code 6
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Kaneka Corporation Osaka Plant

Recent clearances

Product code PDI

FDA records hold no clearances under product code PDI.

Recent recalls

Product code PDI

FDA records show no recalls under product code PDI.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)