DeviceClearance

Product code ODN— Gastroenterology, Urology

NXSTAGE SYSTEM ONE

Classification name
Ultrafiltration-Controlled Nocturnal Dialysate Delivery System
Device class
Class 2
Regulation
21 CFR 876.5860
Advisory panel
Gastroenterology, Urology
Total cleared
2
First cleared
Most recent

FDA classification definition

“Hemodialysis performed with a high permeability hemodialyzer and an ultrafiltration-controlled system. Nocturnal hemodialysis for patients with end-stage renal disease (chronic dialysis) or acute renal failure (acute dialysis) performed with a high permeability hemodialyzer and an ultrafiltration-controlled system.”

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

Market context for product code ODN

FDA has cleared 2 devices under product code ODN between 2014 and 2015, filed by 1 applicant company. 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 ODN

Recent clearances under product code ODN

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