Product Code: KDN FDA class 2 21 CFR 876.5880

System, Perfusion, Kidney

Gastroenterology, Urology

A kidney perfusion system is a device used to mechanically circulate a preservation solution through the vasculature of a harvested donor kidney to maintain metabolic function, reduce cold ischemic injury, and potentially improve post-transplant outcomes. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket clearance. Product code KDN is regulated under 21 CFR 876.5880 in the Gastroenterology, Urology medical specialty. This device is eligible for third-party review under FDA's accredited persons program.

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FEI Numbers

Registration Numbers

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Basic Information

Product Code: KDN
Device Class: FDA class 2
Regulation Number: 876.5880
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 43 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260456	VI°Port Liver Preservation System	Jun 01, 2026	Substantially Equivalent	Traferox Technologies, Inc.
K254305	BAROguard Donor Lung Preservation System	Jan 30, 2026	Substantially Equivalent	Paragonix Technologies, Inc.
K243618	EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)	Jun 17, 2025	Substantially Equivalent	Bridge TO Life
K243870	X°Port Lung Preservation System; X°Port Lung Preservation Solution	May 01, 2025	Substantially Equivalent	Traferox Technologies, Inc.
K243998	DCX Disposable Cassette (DCX)	Apr 25, 2025	Substantially Equivalent	Institut Geroges Lopez
K243384	Belzer UW® Cold Storage Solution (BTLBUW-001)	Mar 31, 2025	Substantially Equivalent	Bridge TO Life
K243840	Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)	Mar 26, 2025	Substantially Equivalent	Bridge TO Life
K240650	LungProtect	Nov 26, 2024	Substantially Equivalent	Traferox Technologies, Inc.
K234060	KIDNEYvault Portable Renal Perfusion System	Oct 23, 2024	Substantially Equivalent	Paragonix Technologies
K230193	Servator P Plus SALF Solution	Sep 21, 2023	Substantially Equivalent	S.A.L.F. Spa
K223874	BAROguard	Aug 15, 2023	Substantially Equivalent	Paragonix Technologies
K211333	KIDNEY ASSIST-transport	Jan 20, 2022	Substantially Equivalent	Xvivo Perfusion AB
K211224	RM4 Control Unit	Oct 15, 2021	Substantially Equivalent	Institut Georges Lopez
K202652	Servator P SALF Solution with THAM	Aug 19, 2021	Substantially Equivalent	S.A.L.F. Spa
K203262	Cannula for Organ Perfusion	Jul 01, 2021	Substantially Equivalent	Bridge TO Life, Ltd.
K201048	SherpaPak Pediatric Liver Transport System	Jul 02, 2020	Substantially Equivalent	Paragonix Technologies
K192869	SherpaPak Lung Preservation System , SherpaPak Liver Transport System	Jan 16, 2020	Unknown	Pragonix Technologies
K191440	Paragonix SherpaPak Pancreas Transport System	Dec 20, 2019	Substantially Equivalent	Paragonix Technologies
K191006	EasiSlush	Sep 24, 2019	Substantially Equivalent	Bridge TO Life, Ltd.
K180481	Servator B SALF Solution	Jun 29, 2018	Substantially Equivalent	S.A.L.F. Spa
K170826	Perfadex Plus	Jun 22, 2018	Substantially Equivalent	Xvivo Perfusion AB
K153384	Low Potassium Dextran Solution with Tris Diluent	Feb 19, 2016	Substantially Equivalent	United Therapeutics Corporation
K151728	CoStorSol plus G	Sep 18, 2015	Substantially Equivalent	Preservation Solutions, Inc.
K143054	Sherpa Pak Kidney Transport System	Nov 25, 2014	Unknown	Paragonix Technologies, Inc.
K133694	SHERPA PAK TRANSPORTER	May 23, 2014	Substantially Equivalent	Paragonix Technologies, Inc.
K111521	WAVES	Feb 16, 2012	Substantially Equivalent	Waters Medical Systems, LLC
K091989	PERFADEX AND PERFADEX WITH THAM	Oct 01, 2010	Substantially Equivalent	Xvivo Perfusion AB
K091245	COSTORSOL	Jun 17, 2009	Substantially Equivalent	Preservation Solutions, Inc.
K083453	COSTORSOL	Jan 21, 2009	Substantially Equivalent	Preservation Solutions, Inc.
K080432	MAPERSOL	Aug 08, 2008	Substantially Equivalent	Preservation Solutions, Inc.
K073693	COSTORSOL	Jul 03, 2008	Substantially Equivalent	Preservation Solutions, Inc.
K042224	RM3 RENAL PRESERVATION SYSTEM	Oct 22, 2004	Substantially Equivalent	Waters Instruments, Inc.
K021362	LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)	Jul 31, 2003	Substantially Equivalent	Organ Recovery Systems, Inc.
K022391	MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION	Oct 21, 2002	Substantially Equivalent	Organ Recovery Systems, Inc.
K013575	KPS-I, THE KIDNEY PERFUSION SOLUTION	Jan 25, 2002	Substantially Equivalent	Organ Recovery Systems, Inc.
K992209	CUSTODIOL	Dec 10, 1999	Substantially Equivalent	Dr. Franz Kohler Chemie GmbH
K990229	HPA PORTABLE KIDNEY PRESERVATION SYSTEM, MODEL J-1000-1	Nov 04, 1999	Substantially Equivalent	Justec Medical Products, Inc.
K972066	BELZER-MPS	Nov 26, 1997	Substantially Equivalent	Trans-Med Corp.
K971571	RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT	Jul 29, 1997	Substantially Equivalent	Waters Instruments, Inc.
K911587	K-SOL(TM)	Nov 01, 1991	Substantially Equivalent	Alcon Laboratories
K864140	KIDNEY PERFUSION MACHINE	Mar 05, 1987	Substantially Equivalent	Advanced Equipment Development, Inc.
K840687	KIDNEY TRANSPLANT CATHETER	Jun 07, 1984	Substantially Equivalent	Warne Surgical Products, Ltd.
K830994	REDOX CONTROLLER	May 27, 1983	Substantially Equivalent	St. Louis Univ. Medical Center