DeviceClearance

Product code FJK— Gastroenterology, Urology

ARTERIOVENOUS BLOOD TUBING SETS

Classification name
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Device class
Class 2
Regulation
21 CFR 876.5820
Advisory panel
Gastroenterology, Urology
Total cleared
77
First cleared
Most recent

Market context for product code FJK

FDA has cleared 77 devices under product code FJK between 1977 and 2026, filed by 51 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 FJK

Adverse events under product code FJK

product code FJK
Death
52
Malfunction
3,430
Total
3,482

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 FJK

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