KIDNEY ASSIST-transport

FDA 510(k) K211333 · Xvivo Perfusion AB

Substantially Equivalent

510(k) numberK211333

Submission

Device name
KIDNEY ASSIST-transport
Applicant
Xvivo Perfusion AB
Goteborg, SE
Received
May 3, 2021
Decision date
January 20, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KDN – System, Perfusion, Kidney
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5880
Specialty
Gastroenterology, Urology

Other 510(k)s with product code KDN

510(k)DeviceApplicantDecision
K261644Perfadex PlusKDN · Traditional Xvivo Perfusion AB07/23/2026SE
K260456VI°Port™ Liver Preservation SystemKDN · Traditional Traferox Technologies, Inc.06/01/2026SE
K254305BAROguard Donor Lung Preservation SystemKDN · Special Paragonix Technologies, Inc.01/30/2026SE
K243618EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)KDN · Traditional Bridge TO Life06/17/2025SE
K243870X°Port Lung Preservation System; X°Port Lung Preservation SolutionKDN · Traditional Traferox Technologies, Inc.05/01/2025SE
K243998DCX Disposable Cassette (DCX)KDN · Traditional Institut Geroges Lopez04/25/2025SE
K243384Belzer UW® Cold Storage Solution (BTLBUW-001)KDN · Traditional Bridge TO Life03/31/2025SE
K243840Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)KDN · Traditional Bridge TO Life03/26/2025SE
K240650LungProtectKDN · Traditional Traferox Technologies, Inc.11/26/2024SE
K234060KIDNEYvault Portable Renal Perfusion SystemKDN · Traditional Paragonix Technologies10/23/2024SE

More from Paragonix Technologies

510(k)DeviceDecision
K261644Perfadex PlusKDN · Traditional 07/23/2026SE
K170826Perfadex PlusKDN · Traditional 06/22/2018SE
K091989Perfadex and Perfadex with ThamKDN · Special 10/01/2010SE

Questions and answers

When was KIDNEY ASSIST-transport cleared by the FDA?

KIDNEY ASSIST-transport (K211333) received a 510(k) decision of Substantially Equivalent on January 20, 2022, 262 days after the submission was received.

What is the product code of K211333?

The FDA product code is KDN – System, Perfusion, Kidney, a Class II (moderate risk) device regulated under 21 CFR 876.5880.