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KDN — System, Perfusion, Kidney Class II

FDA Device Classification

Classification Details

Product Code
KDN
Device Class
Class II
Regulation Number
876.5880
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K254305paragonix technologiesBAROguard Donor Lung Preservation SystemJanuary 30, 2026
K243618bridge to lifeEasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)June 17, 2025
K243870traferox technologiesX°Port Lung Preservation System; X°Port Lung Preservation SolutionMay 1, 2025
K243998institut geroges lopezDCX Disposable Cassette (DCX)April 25, 2025
K243384bridge to lifeBelzer UW® Cold Storage Solution (BTLBUW-001)March 31, 2025
K243840bridge to lifeBelzer MPS® (UW Machine Perfusion Solution) (BMPS-001)March 26, 2025
K240650traferox technologiesLungProtectNovember 26, 2024
K234060paragonix technologiesKIDNEYvault Portable Renal Perfusion SystemOctober 23, 2024
K230193s.a.l.fServator P Plus SALF SolutionSeptember 21, 2023
K223874paragonix technologiesBAROguardAugust 15, 2023
K211333xvivo perfusionKIDNEY ASSIST-transportJanuary 20, 2022
K211224institut georges lopezRM4 Control UnitOctober 15, 2021
K202652s.a.l.fServator P SALF Solution with THAMAugust 19, 2021
K203262bridge to lifeCannula for Organ PerfusionJuly 1, 2021
K201048paragonix technologiesSherpaPak Pediatric Liver Transport SystemJuly 2, 2020
K192869pragonix technologiesSherpaPak Lung Preservation System , SherpaPak Liver Transport SystemJanuary 16, 2020
K191440paragonix technologiesParagonix SherpaPak Pancreas Transport SystemDecember 20, 2019
K191006bridge to lifeEasiSlushSeptember 24, 2019
K180481s.a.l.fServator B SALF SolutionJune 29, 2018
K170826xvivo perfusionPerfadex PlusJune 22, 2018