KDN · Class II · 21 CFR 876.5880

FDA Product Code KDN: System, Perfusion, Kidney

Leading manufacturers include Preservation Solutions, Inc., Paragonix Technologies and Xvivo Perfusion AB.

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 Jul 23, 2026
Perfadex Plus
K261644
Xvivo Perfusion AB
Gastroenterology & Urology · 66d
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 Feb 19, 2016
Low Potassium Dextran Solution with Tris Diluent
K153384
United Therapeutics Corporation
Gastroenterology & Urology · 88d
Cleared Sep 18, 2015
CoStorSol plus G
K151728
Preservation Solutions, Inc.
Gastroenterology & Urology · 84d

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 →