Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medicon Hellas S.A · 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) |
|---|---|---|---|---|---|
| K232404 | CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDE | Medicon Hellas S.A | 2024-08-09 | 365 | 0 |
| K200898 | Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hell | Medicon Hellas S.A | 2021-09-21 | 536 | 0 |
| K062746 | FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 | Medicon Hellas S.A | 2006-11-20 | 67 | 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