OVLHumanitarian device exemption

Hemodialyzer, High Cut-Off

Unknown

OVL is the FDA product code for Hemodialyzer, High Cut-Off. FDA's definition for this code reads: "Removal of free light chains for the treatment of dialysis dependent acute renal failure secondary to cast nephropathy in patients with multiple myeloma". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: OVL
Device name: Hemodialyzer, High Cut-Off
FDA definition: Removal of free light chains for the treatment of dialysis dependent acute renal failure secondary to cast nephropathy in patients with multiple myeloma.
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

No registered establishment in MDM’s records lists product code OVL.

Recent clearances

Product code OVL

FDA records hold no clearances under product code OVL.

Recent recalls

Product code OVL

FDA records show no recalls under product code OVL.

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)