Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Heraeus Med GmbH · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K973466 | HANAULUX BLUE 75 AND HANAULUX BLUE 120 | Heraeus Med GmbH | 1997-10-24 | 70 | 0 |
| K970886 | HANAULUX BLUE 80 HOSPITAL | Heraeus Med GmbH | 1997-04-16 | 69 | 1 |
| K954169 | HANAULUX BLUE 30 & 80 | Heraeus Med GmbH | 1996-02-01 | 149 | 1 |
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