Data / Medical devices / Germany / DR. Franz Kohler Chemie GMBH
DR. Franz Kohler Chemie GMBH: FDA-registered device maker in BENSHEIM Hesse, Germany, 5 510(k) clearances
DR. Franz Kohler Chemie GMBH is registered with the FDA (registration 9615922) in BENSHEIM Hesse, Germany. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated April 24, 2020. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 9615922
- FEI number
- 3001640191
- Address
- Werner-Von-Siemens-Str. 14-28, BENSHEIM Hesse, Germany, D-64625
- Owner or operator
- DR. FRANZ KOHLER CHEMIE GMBH (9034968)
- Roles
- Manufacturer
- First device listed
- October 29, 2007
- Registered through
- 2027
- Brand names listed
- Custodiol, Custodiol HTK Solution, Custodiol Htk Solution
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Set, Perfusion, Kidney, Disposable | KDL | 2 | Manufacturer | accessdata.fda.gov |
| System And Accessories, Isolated Heart, Transport And Preservation | MSB | 2 | Manufacturer | accessdata.fda.gov |
| System, Perfusion, Kidney | KDN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 24, 2020 | K192408 | Custodiol HTK Solution | KDL | Substantially Equivalent | Dr. Franz Kohler Chemie GmbH | accessdata.fda.gov |
| February 28, 2005 | K043461 | CUSTODIOL | KDL | Substantially Equivalent | Dr. Franz Kohler Chemie GmbH | accessdata.fda.gov |
| April 5, 2004 | K032794 | CUSTODIOL | MSB | Substantially Equivalent | Dr. Franz Kohler Chemie GmbH | accessdata.fda.gov |
| January 6, 2003 | K020924 | CUSTODIOL HTK SOLUTION | KDL | Substantially Equivalent | Dr. Franz Kohler Chemie GmbH | accessdata.fda.gov |
| December 10, 1999 | K992209 | CUSTODIOL | KDN | Substantially Equivalent | Dr. Franz Kohler Chemie GmbH | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 9, 2024 | 95182 | Class II | Ongoing | Custodiol HTK Solution, 500ml bottle. 10 per carton. | Potential for particles to be present in solution. | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Perfusion, Kidney, Disposable
- All makers of System And Accessories, Isolated Heart, Transport And Preservation
- All makers of System, Perfusion, Kidney
Updated September 26, 2024. 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.