FDA Product Code KDL: Set, Perfusion, Kidney, Disposable
Leading manufacturers include Institut Georges Lopez, Dr. Franz Kohler Chemie GmbH and S.A.L.F. Spa.
19
Total
19
Cleared
231d
Avg days
1976
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Review times increasing: avg
266d
recently vs 229d historically
FDA 510(k) Cleared Set, Perfusion, Kidney, Disposable Devices (Product Code KDL)
19 devices
Cleared
Jan 24, 2025
OrganProtex HTK Solution
Bridge TO Life, Ltd.
Gastroenterology & Urology
266d
Cleared
Jun 14, 2022
PERF-GEN Pulsatile Perfusion Solution
Institut Georges Lopez
Gastroenterology & Urology
32d
Cleared
Jun 14, 2022
BEL-GEN Cold Storage Solution
Institut Georges Lopez
Gastroenterology & Urology
32d
Cleared
Dec 20, 2021
Servator M SALF Solution
S.A.L.F. Spa
Gastroenterology & Urology
188d
Cleared
Apr 24, 2020
Custodiol HTK Solution
Dr. Franz Kohler Chemie GmbH
Gastroenterology & Urology
233d
Cleared
Nov 19, 1976
PERFUSION TUBING SET
Shiley, Inc.
Gastroenterology & Urology
22d
About Product Code KDL - Regulatory Context
510(k) Submission Activity
19 total 510(k) submissions under product code KDL since 1976, with 19 receiving FDA clearance (average review time: 231 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - KDL Product Code
Recent submissions under KDL have taken an average of 266 days to reach a decision - up from 229 days historically. Manufacturers should account for longer review timelines in current project planning.
KDL devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →