DeviceClearance

Product code KDL— Gastroenterology, Urology

BEL-GEN COLD STORAGE SOLUTION

Classification name
Set, Perfusion, Kidney, Disposable
Device class
Class 2
Regulation
21 CFR 876.5880
Advisory panel
Gastroenterology, Urology
Total cleared
19
First cleared
Most recent

Market context for product code KDL

FDA has cleared 19 devices under product code KDL between 1976 and 2025, filed by 14 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 KDL

Recent clearances under product code KDL

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