DeviceClearance

Product code ONW— Gastroenterology, Urology

2008K@HOME HEMODIALYSIS MACHINE

Classification name
Hemodialysis System For Home Use
Device class
Class 2
Regulation
21 CFR 876.5860
Advisory panel
Gastroenterology, Urology
Total cleared
4
First cleared
Most recent

FDA classification definition

“To treat and provide hemodialysis therapy at home for chronic renal failure patients.”

— U.S. Food and Drug Administration, device classification record for product code ONW under 21 CFR 876.5860, via openFDA

Market context for product code ONW

FDA has cleared 4 devices under product code ONW between 2011 and 2024, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code ONW

Recent clearances under product code ONW

Data sourced from openFDA. This site is unofficial and independent of the FDA.