Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Axiom Usa., Inc. — 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) |
|---|---|---|---|---|---|
| K033015 | AXIOM BIOLASER LLLT SERIES-3 | Axiom Usa., Inc. | 2003-11-25 | 60 | 0 |
| K030622 | AXIOM BIOLASER LLLT SERIES-1 | Axiom Usa., Inc. | 2003-09-09 | 194 | 0 |
| K022602 | DRX3000 | Axiom Usa., Inc. | 2003-01-23 | 170 | 0 |
| K023160 | DRX5000 | Axiom Usa., Inc. | 2002-12-20 | 88 | 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