PBNHumanitarian device exemption

Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients

Unknown

PBN is the FDA product code for Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients. FDA's definition for this code reads: "Removal of plasma components to treat focal glomerulosclerosis". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: PBN
Device name: Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients
FDA definition: Removal of plasma components to treat focal glomerulosclerosis
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

Recent clearances

Product code PBN

FDA records hold no clearances under product code PBN.

Recent recalls

Product code PBN

FDA records show no recalls under product code PBN.

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)