Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Dr. Franz Kohler Chemie GmbH · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
210 daysmedian FDA review time
291 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192408 | Custodiol HTK Solution | Dr. Franz Kohler Chemie GmbH | 2020-04-24 | 233 | 1 |
| K043461 | CUSTODIOL | Dr. Franz Kohler Chemie GmbH | 2005-02-28 | 75 | 0 |
| K032794 | CUSTODIOL | Dr. Franz Kohler Chemie GmbH | 2004-04-05 | 210 | 0 |
| K020924 | CUSTODIOL HTK SOLUTION | Dr. Franz Kohler Chemie GmbH | 2003-01-06 | 291 | 0 |
| K992209 | CUSTODIOL | Dr. Franz Kohler Chemie GmbH | 1999-12-10 | 163 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda