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# New Fresenius Hemodialysis Device Cleared
- URL: https://www.fdaweb.com/new-fresenius-hemodialysis-device-cleared/
- Published: 2024-02-09T12:00:00.000Z
- Updated: 2026-09-14T14:22:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156328

FDA has cleared a Fresenius Medical Care 510(k) for its 5008X Hemodialysis High-Volume System. “Unlike conventional high-flux hemodialysis, which primarily employs diffusion to remove small molecules and fluid from the blood, high-volume hemodiafiltration incorporates both diffusion and convection techniques to eliminate larger molecules and effectively manage fluid replacement through convection,” the company says. Along with the companion FX CorAL dialyzer, the 5008X Hemodialysis System “combines the latest device engineering and cutting-edge membrane technologies required to make high-volume hemodiafiltration possible,” it says.