KDN · Class II · 21 CFR 876.5880

FDA Product Code KDN: System, Perfusion, Kidney

Leading manufacturers include Paragonix Technologies, S.A.L.F. Spa and Traferox Technologies, Inc..

44
Total
44
Cleared
172d
Avg days
1983
Since
Growing category - 10 submissions in the last 2 years vs 2 in the prior period
Review times improving: avg 149d recently vs 179d historically

FDA 510(k) Cleared System, Perfusion, Kidney Devices (Product Code KDN)

44 devices
1–24 of 44
Cleared Jun 01, 2026
VI°Port™ Liver Preservation System
K260456
Traferox Technologies, Inc.
Gastroenterology & Urology · 110d
Cleared Jan 30, 2026
BAROguard Donor Lung Preservation System
K254305
Paragonix Technologies, Inc.
Gastroenterology & Urology · 30d
Cleared Jun 17, 2025
EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)
K243618
Bridge TO Life
Gastroenterology & Urology · 207d
Cleared May 01, 2025
X°Port Lung Preservation System
K243870
Traferox Technologies, Inc.
Gastroenterology & Urology · 135d
Cleared Apr 25, 2025
DCX Disposable Cassette (DCX)
K243998
Institut Geroges Lopez
Gastroenterology & Urology · 120d
Cleared Mar 31, 2025
Belzer UW® Cold Storage Solution (BTLBUW-001)
K243384
Bridge TO Life
Gastroenterology & Urology · 151d
Cleared Mar 26, 2025
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)
K243840
Bridge TO Life
Gastroenterology & Urology · 103d
Cleared Nov 26, 2024
LungProtect
K240650
Traferox Technologies, Inc.
Gastroenterology & Urology · 264d
Cleared Oct 23, 2024
KIDNEYvault Portable Renal Perfusion System
K234060
Paragonix Technologies
Gastroenterology & Urology · 306d
Cleared Sep 21, 2023
Servator P Plus SALF Solution
K230193
S.A.L.F. Spa
Gastroenterology & Urology · 240d
Cleared Aug 15, 2023
BAROguard
K223874
Paragonix Technologies
Gastroenterology & Urology · 235d
Cleared Jan 20, 2022
KIDNEY ASSIST-transport
K211333
Xvivo Perfusion AB
Gastroenterology & Urology · 262d
Cleared Oct 15, 2021
RM4 Control Unit
K211224
Institut Georges Lopez
Gastroenterology & Urology · 175d
Cleared Aug 19, 2021
Servator P SALF Solution with THAM
K202652
S.A.L.F. Spa
Gastroenterology & Urology · 339d
Cleared Jul 01, 2021
Cannula for Organ Perfusion
K203262
Bridge TO Life, Ltd.
Gastroenterology & Urology · 238d
Cleared Jul 02, 2020
SherpaPak Pediatric Liver Transport System
K201048
Paragonix Technologies
Gastroenterology & Urology · 72d
Cleared Jan 16, 2020
SherpaPak Lung Preservation System , SherpaPak Liver Transport System
K192869
Pragonix Technologies
Gastroenterology & Urology · 101d
Cleared Dec 20, 2019
Paragonix SherpaPak Pancreas Transport System
K191440
Paragonix Technologies
Gastroenterology & Urology · 204d
Cleared Sep 24, 2019
EasiSlush
K191006
Bridge TO Life, Ltd.
Gastroenterology & Urology · 161d
Cleared Jun 29, 2018
Servator B SALF Solution
K180481
S.A.L.F. Spa
Gastroenterology & Urology · 126d
Cleared Jun 22, 2018
Perfadex Plus
K170826
Xvivo Perfusion AB
Gastroenterology & Urology · 459d
Cleared Nov 01, 1991
K-SOL(TM)
K911587
Alcon Laboratories
Gastroenterology & Urology · 206d

About Product Code KDN - Regulatory Context

510(k) Submission Activity

44 total 510(k) submissions under product code KDN since 1983, with 44 receiving FDA clearance (average review time: 172 days).

Submission volume has increased in recent years - 10 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - KDN Product Code

Recent submissions under KDN have taken an average of 149 days to reach a decision - down from 179 days historically, suggesting improved FDA processing for this classification.

KDN devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →