Byonyks, a medical device company focused on advancing dialysis care, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Byonyks X1 APD Cycler, an automated peritoneal dialysis (APD) system.
The Byonyks X1 APD Cycler is indicated for the treatment of acute and chronic peritoneal dialysis, and is cleared for use in both clinical and home environments. This system uses a peristaltic pumping mechanism to manage dialysate flow as prescribed by a physician and supports personalized, programmable dialysis therapy.
“This clearance reflects years of rigorous development, testing, and teamwork,” said Farrukh Usman, Founder & CEO of Byonyks. “It brings us one step closer to our mission of making dialysis care safer, more accessible, and better suited to patients’ everyday lives.”
The Byonyks X1 APD Cycler includes a compact main control unit and a disposable tubing set. The device is prescription-use only and is designed to support both in-center and at-home peritoneal dialysis, aligning with global trends toward patient-centric renal care.
This regulatory milestone marks a significant step forward for Byonyks as it continues its efforts to deliver high-quality, patient-friendly dialysis technologies that meet international standards.
For more information, visit www.byonyks.com.