BEL-GEN Cold Storage Solution

FDA 510(k) K221387 · Institut Georges Lopez

Substantially Equivalent

510(k) numberK221387

Submission

Device name
BEL-GEN Cold Storage Solution
Applicant
Institut Georges Lopez
Lissieu, FR
Received
May 13, 2022
Decision date
June 14, 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
KDL – Set, Perfusion, Kidney, Disposable
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5880
Specialty
Gastroenterology, Urology

Other 510(k)s with product code KDL

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K241239OrganProtex HTK SolutionKDL · Traditional Bridge TO Life, Ltd.01/24/2025SE
K221386PERF-GEN Pulsatile Perfusion SolutionKDL · Traditional Institut Georges Lopez06/14/2022SE
K211842Servator M SALF SolutionKDL · Traditional S.A.L.F. Spa12/20/2021SE
K192408Custodiol HTK SolutionKDL · Traditional Dr. Franz Kohler Chemie GmbH04/24/2020SE
K170150Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC…KDL · Traditional S.A.L.F. Spa10/20/2017SE
K121736Perf-Gen Pulsatile Perfusion SolutionKDL · Traditional Waters Medical Systems, LLC08/16/2013SE
K121618Bel-Gen Cold Storage SolutionKDL · Traditional Waters Medical Systems, LLC06/14/2013SE
K091656SPS-1TM Static Preservation Solution, Models SPS-1-500 ML, SPS 1-1L, SPS-1-2LKDL · Traditional Organ Recovery Systems, Inc.03/11/2010SE
K043461CustodiolKDL · Traditional Dr. Franz Kohler Chemie GmbH02/28/2005SE
K020924Custodiol HTK SolutionKDL · Traditional Dr. Franz Kohler Chemie GmbH01/06/2003SE

More from Dr. Franz Kohler Chemie GmbH

510(k)DeviceDecision
K221386PERF-GEN Pulsatile Perfusion SolutionKDL · Traditional 06/14/2022SE
K211224RM4 Control UnitKDN · Traditional 10/15/2021SE

Questions and answers

When was BEL-GEN Cold Storage Solution cleared by the FDA?

BEL-GEN Cold Storage Solution (K221387) received a 510(k) decision of Substantially Equivalent on June 14, 2022, 32 days after the submission was received.

What is the product code of K221387?

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