HDE supplement
H130001 S005: LIXELLE® ß2-microglobulin Apheresis Column (LIXELLE® S-15 (150 mL capacity) (LIXELLE® S-25 (250 mL capacity) (LIXELLE® S
FDA HDE supplement · normal 75 day track · Kaneka Pharma America, LLC
Key facts
| Original HDE | H130001 |
|---|---|
| Supplement number | S005 |
| Supplement type | normal 75 day track |
| Reason for the supplement | change design/components/specifications/material |
| Trade name | LIXELLE® ß2-microglobulin Apheresis Column (LIXELLE® S-15 (150 mL capacity) (LIXELLE® S-25 (250 mL capacity) (LIXELLE® S |
| Generic name | Beta 2-microglobulin apheresis column |
| Applicant | Kaneka Pharma America, LLC |
| Product code | PDI |
| Received date | Jan 29, 2026 |
| Decision date | Apr 9, 2026 |
At a glance
- No Approval order on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE supplements
An HDE supplement asks FDA to approve a change to a Humanitarian Use Device that already holds a humanitarian device exemption.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: