DeviceClearance

Product code FKQ— Gastroenterology, Urology

HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES

Classification name
System, Dialysate Delivery, Central Multiple Patient
Device class
Class 2
Regulation
21 CFR 876.5820
Advisory panel
Gastroenterology, Urology
Total cleared
61
First cleared
Most recent

Market context for product code FKQ

FDA has cleared 61 devices under product code FKQ between 1976 and 2006, filed by 39 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 FKQ

Adverse events under product code FKQ

product code FKQ
Other
1
Total
1

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 FKQ

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