Dr. Franz Kohler Chemie GmbH: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Dr. Franz Kohler Chemie GmbH” (first 1999, latest 2020), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 210 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 233 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Dr. Franz Kohler Chemie GmbH took a median 233 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 156 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KDL | Set, Perfusion, Kidney, Disposable | 3 | 3 |
| KDN | System, Perfusion, Kidney | 1 | 1 |
| MSB | System And Accessories, Isolated Heart, Transport And Preservation | 1 | 1 |
Review panels
Most recent Dr. Franz Kohler Chemie GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192408 | Custodiol HTK Solution | KDL | 2020-04-24 | 233 |
| K043461 | CUSTODIOL | KDL | 2005-02-28 | 75 |
| K032794 | CUSTODIOL | MSB | 2004-04-05 | 210 |
| K020924 | CUSTODIOL HTK SOLUTION | KDL | 2003-01-06 | 291 |
| K992209 | CUSTODIOL | KDN | 1999-12-10 | 163 |
Recalls
openFDA lists no recalls under a recalling firm named Dr. Franz Kohler Chemie GmbH.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Dr. Franz Kohler Chemie GmbH?
FDA lists 5 510(k) clearances under the applicant name “Dr. Franz Kohler Chemie GmbH” (first 1999, latest 2020), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Dr. Franz Kohler Chemie GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dr. Franz Kohler Chemie GmbH is 210 days.
Which FDA product codes appear under Dr. Franz Kohler Chemie GmbH?
The most frequent FDA product codes under this applicant name are KDL (Set, Perfusion, Kidney, Disposable, 3); KDN (System, Perfusion, Kidney, 1); MSB (System And Accessories, Isolated Heart, Transport And Preservation, 1).
Next steps
- See all 5 Dr. Franz Kohler Chemie GmbH clearances with predicates and recalls
- Run predicate analysis for product code KDL, Dr. Franz Kohler Chemie GmbH's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.