Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Anodia Systems — 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) |
|---|---|---|---|---|---|
| K023896 | C-1890 | Anodia Systems | 2003-06-19 | 209 | 0 |
| K023815 | C-1805M | Anodia Systems | 2003-06-19 | 216 | 0 |
| K023213 | RDH-2000 | Anodia Systems | 2003-01-16 | 112 | 0 |
| K925378 | STERI-SOL SOLUTION, MODIFICATION | Anodia Systems | 1993-07-22 | 289 | 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