DeviceClearance

Product code KDI— Gastroenterology, Urology

NXSTAGE SYSTEM ONE

Classification name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device class
Class 2
Regulation
21 CFR 876.5860
Advisory panel
Gastroenterology, Urology
Total cleared
345
First cleared
Most recent

Market context for product code KDI

FDA has cleared 345 devices under product code KDI between 1978 and 2026, filed by 83 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

last 15 years

Top applicants under product code KDI

Adverse events under product code KDI

product code KDI
Death
352
Injury
1,474
Malfunction
12,534
Other
4
Total
14,364

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code KDI

1–100 of 345

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