Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Heraeus Kulzer GmbH & Co. KG · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K031673 | REFOBACIN -PALACOS G | Heraeus Kulzer GmbH & Co. KG | 2004-05-25 | 361 | 1 |
| K030902 | PALACOS R | Heraeus Kulzer GmbH & Co. KG | 2003-09-23 | 183 | 0 |
| K030903 | OSTEOPAL | Heraeus Kulzer GmbH & Co. KG | 2003-09-23 | 183 | 0 |
| K022251 | PALABOND | Heraeus Kulzer GmbH & Co. KG | 2003-02-26 | 229 | 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