Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Axiom, 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) |
|---|---|---|---|---|---|
| K883887 | AXIOM ATRAUM WOUND DRAINS | Axiom, Inc. | 1989-02-17 | 157 | 0 |
| K842443 | AXIOM STABLE II TRIGLYCERIDES TEST | Axiom, Inc. | 1984-09-13 | 84 | 0 |
| K842442 | AXIOM STABLE II URIC ACID TEST | Axiom, Inc. | 1984-08-16 | 56 | 0 |
| K842441 | AXIOM STABLE II CHOLESTEROL TEST | Axiom, Inc. | 1984-07-25 | 34 | 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