Data / Medical devices / Set, Perfusion, Kidney, Disposable
Set, Perfusion, Kidney, Disposable (KDL): 13 FDA-registered makers in 5 countries
13 establishments in 5 countries are registered with the FDA to make Set, Perfusion, Kidney, Disposable (product code KDL, Class 2, 21 CFR 876.5880). 5 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 19 510(k) clearances under this code, the latest on January 24, 2025, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KDL
- Device class
- 2
- Regulation
- 876.5880
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| France | 2 |
| Germany | 1 |
| Italy | 1 |
| Austria | 1 |
Makers of Set, Perfusion, Kidney, Disposable
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| DR. Franz Kohler Chemie GMBH | BENSHEIM Hesse, Germany | Manufacturer | 3 | April 24, 2020 | 0 | 1 | 0 | api.fda.gov |
| Institut Georges Lopez | Lissieu Auvergne-Rhone-Alpes, France | Manufacturer | 2 | June 14, 2022 | 0 | 0 | 0 | api.fda.gov |
| Institut Georges Lopez | ST LAURENT DE CHAMOUSSET Rhone, France | Manufacturer | 2 | June 14, 2022 | 0 | 0 | 0 | api.fda.gov |
| S.A.L.F. Laboratorio Framacologico | Cenate Scotto Bergamo, Italy | Manufacturer | 2 | December 20, 2021 | 0 | 0 | 0 | api.fda.gov |
| Organ Recovery Systems, Inc. | Itasca, IL, United States | Manufacturer | 1 | March 11, 2010 | 0 | 1 | 0 | api.fda.gov |
| August Bioservices, LLC | Nashville, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biocure Solutions, LLC Dba Biocure, Inc. | Peachtree Corners, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biovire, Inc. | Brighton, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bridge to Life Ltd | Duluth, GA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fresenius Kabi Austria GMBH | GRAZ Steiermark, Austria | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lifecycle Biotechnologies, LLC | Cleburne, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marizyme, Inc. | West Palm Bch, FL, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Us Specialty Formulations | Allentown, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 24, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.