KDL · Class II · 21 CFR 876.5880

FDA Product Code KDL: Set, Perfusion, Kidney, Disposable

Leading manufacturers include Dr. Franz Kohler Chemie GmbH, Waters Medical Systems, LLC 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
1–19 of 19
Cleared Jan 24, 2025
OrganProtex HTK Solution
K241239
Bridge TO Life, Ltd.
Gastroenterology & Urology · 266d
Cleared Jun 14, 2022
PERF-GEN Pulsatile Perfusion Solution
K221386
Institut Georges Lopez
Gastroenterology & Urology · 32d
Cleared Jun 14, 2022
BEL-GEN Cold Storage Solution
K221387
Institut Georges Lopez
Gastroenterology & Urology · 32d
Cleared Dec 20, 2021
Servator M SALF Solution
K211842
S.A.L.F. Spa
Gastroenterology & Urology · 188d
Cleared Apr 24, 2020
Custodiol HTK Solution
K192408
Dr. Franz Kohler Chemie GmbH
Gastroenterology & Urology · 233d
Cleared Oct 20, 2017
Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags
K170150
S.A.L.F. Spa
Gastroenterology & Urology · 276d
Cleared Aug 16, 2013
PERF-GEN PULSATILE PERFUSION SOLUTION
K121736
Waters Medical Systems, LLC
Gastroenterology & Urology · 429d
Cleared Jun 14, 2013
BEL-GEN COLD STORAGE SOLUTION
K121618
Waters Medical Systems, LLC
Gastroenterology & Urology · 378d
Cleared Mar 11, 2010
SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L
K091656
Organ Recovery Systems, Inc.
Gastroenterology & Urology · 275d
Cleared Feb 28, 2005
CUSTODIOL
K043461
Dr. Franz Kohler Chemie GmbH
Gastroenterology & Urology · 75d
Cleared Jan 06, 2003
CUSTODIOL HTK SOLUTION
K020924
Dr. Franz Kohler Chemie GmbH
Gastroenterology & Urology · 291d
Cleared Sep 25, 1997
GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET
K955497
Cobe Renal Care, Inc.
Gastroenterology & Urology · 664d
Cleared Apr 22, 1996
VIASPAN (BELZER UW - CSS)
K944866
The Dupont Merck Pharmaceutical Co.
Gastroenterology & Urology · 567d
Cleared Nov 28, 1989
MOP CATHETER
K891239
Bivona Medical Technologies
Gastroenterology & Urology · 266d
Cleared Jan 26, 1989
EURO-COLLINS SOLUTION SETS
K884609
Fresenius USA, Inc.
Gastroenterology & Urology · 80d
Cleared Apr 27, 1978
H.P. MEDICAL GRADE SILICONE TUBING
K780470
Dow Corning Corp. Healthcare Industries Materials
Gastroenterology & Urology · 36d
Cleared Nov 19, 1976
PERFUSION TUBING SET
K760922
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 →