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# Quanta Dialysis Home Dialysis Device Cleared
- URL: https://www.fdaweb.com/quanta-dialysis-home-dialysis-device-cleared/
- Published: 2024-11-04T12:00:00.000Z
- Updated: 2026-09-14T14:46:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158118

FDA has cleared a Quanta Dialysis Technologies 510(k) for the use of its Quanta Dialysis System in the home setting. The device is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in the home by trained patients in tandem with a trained care partner. It uses the company’s SC+ Blood Tube Set, which is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis.

The clearance is based on clinical trial data, including a study involving 32 patients who received standard in-center hemodialysis while training to use the Quanta Dialysis System, before transitioning to perform home hemodialysis four times per week for eight weeks, according to the company. “The study demonstrated the device to be safe and effective, with more than 90% of patients electing to continue using the device after completing the trial,” it says.