Atlas FDA

KDN

44 FDA 510(k) clearances · Product code

161 daysmedian time to decision
306 days90th percentile
44clearances measured

FDA profile

Official device name
System, Perfusion, Kidney
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5880
Medical specialty
Gastroenterology, Urology
Flags
Third-party review eligible
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Perfadex Plus (K261644)Xvivo Perfusion AB2026-07-23
VI°Port™ Liver Preservation System (K260456)Traferox Technologies, Inc.2026-06-01
BAROguard Donor Lung Preservation System (K254305)Paragonix Technologies, Inc.2026-01-30
EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) (K243618)Bridge TO Life2025-06-17
X°Port Lung Preservation System; X°Port Lung Preservation Solution (K243870)Traferox Technologies, Inc.2025-05-01
DCX Disposable Cassette (DCX) (K243998)Institut Geroges Lopez2025-04-25
Belzer UW® Cold Storage Solution (BTLBUW-001) (K243384)Bridge TO Life2025-03-31
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) (K243840)Bridge TO Life2025-03-26
LungProtect (K240650)Traferox Technologies, Inc.2024-11-26
KIDNEYvault Portable Renal Perfusion System (K234060)Paragonix Technologies2024-10-23
Servator P Plus SALF Solution (K230193)S.A.L.F. Spa2023-09-21
BAROguard (K223874)Paragonix Technologies2023-08-15
KIDNEY ASSIST-transport (K211333)Xvivo Perfusion AB2022-01-20
RM4 Control Unit (K211224)Institut Georges Lopez2021-10-15
Servator P SALF Solution with THAM (K202652)S.A.L.F. Spa2021-08-19
Cannula for Organ Perfusion (K203262)Bridge TO Life, Ltd.2021-07-01
SherpaPak Pediatric Liver Transport System (K201048)Paragonix Technologies2020-07-02
SherpaPak Lung Preservation System , SherpaPak Liver Transport System (K192869)Pragonix Technologies2020-01-16
Paragonix SherpaPak Pancreas Transport System (K191440)Paragonix Technologies2019-12-20
EasiSlush (K191006)Bridge TO Life, Ltd.2019-09-24
Servator B SALF Solution (K180481)S.A.L.F. Spa2018-06-29
Perfadex Plus (K170826)Xvivo Perfusion AB2018-06-22
Low Potassium Dextran Solution with Tris Diluent (K153384)United Therapeutics Corporation2016-02-19
CoStorSol plus G (K151728)Preservation Solutions, Inc.2015-09-18
Sherpa Pak Kidney Transport System (K143054)Paragonix Technologies, Inc.2014-11-25
SHERPA PAK TRANSPORTER (K133694)Paragonix Technologies, Inc.2014-05-23
WAVES (K111521)Waters Medical Systems, LLC2012-02-16
PERFADEX AND PERFADEX WITH THAM (K091989)Xvivo Perfusion AB2010-10-01
COSTORSOL (K091245)Preservation Solutions, Inc.2009-06-17
COSTORSOL (K083453)Preservation Solutions, Inc.2009-01-21
MAPERSOL (K080432)Preservation Solutions, Inc.2008-08-08
COSTORSOL (K073693)Preservation Solutions, Inc.2008-07-03
RM3 RENAL PRESERVATION SYSTEM (K042224)Waters Instruments, Inc.2004-10-22
LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) (K021362)Organ Recovery Systems, Inc.2003-07-31
MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION (K022391)Organ Recovery Systems, Inc.2002-10-21
KPS-I, THE KIDNEY PERFUSION SOLUTION (K013575)Organ Recovery Systems, Inc.2002-01-25
CUSTODIOL (K992209)Dr. Franz Kohler Chemie GmbH1999-12-10
HPA PORTABLE KIDNEY PRESERVATION SYSTEM, MODEL J-1000-1 (K990229)Justec Medical Products, Inc.1999-11-04
BELZER-MPS (K972066)Trans-Med Corp.1997-11-26
RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT (K971571)Waters Instruments, Inc.1997-07-29
K-SOL(TM) (K911587)Alcon Laboratories1991-11-01
KIDNEY PERFUSION MACHINE (K864140)Advanced Equipment Development, Inc.1987-03-05
KIDNEY TRANSPLANT CATHETER (K840687)Warne Surgical Products, Ltd.1984-06-07
REDOX CONTROLLER (K830994)St. Louis Univ. Medical Center1983-05-27

Track KDN automatically

Every clearance here is in the API, with alerts when new ones post.