Medical Device Manufacturer · US , Waltham , MA

Fresenius Medical Care Renal Therapies Group, LLC - FDA 510(k) Cleare...

53 submissions · 53 cleared · Since 2013

Recent clearances: multiFiltratePRO System, Careflux H60, NxStage System One with NxView

View 53 510(k) Devices ↓ Official Website

Total

Cleared

Denied

Fresenius Medical Care Renal Therapies Group, LLC is a medical device manufacturer based in Waltham, US. The company specializes in renal therapy and dialysis technologies.

The company has received 53 FDA 510(k) clearances from 53 total submissions since 2013. 96% of submissions focus on Gastroenterology & Urology devices, reflecting the company's core expertise in dialysis and renal replacement therapies. The latest clearance was in 2026, confirming active regulatory engagement.

Recent cleared devices include hemodialysis systems, dialyzers, body composition monitors, and dialysate concentrates. The company's product portfolio addresses in-center dialysis, home therapies, and advanced fluid management solutions for kidney disease patients.

Explore the complete list of device names, product codes, and clearance dates in the database above.

1 device has linked clinical trial registered on ClinicalTrials.gov.

Fresenius Medical Care Renal Therapies Group, LLC is one of 25982 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.