Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
LDO · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K043384 | VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 A | Ortho-Clinical Diagnostics, Inc. | 2005-02-07 | 60 | 0 |
| K841556 | HEART - AID ALS, 95 | Cardiac Resucitator Corp. | 1984-07-19 | 94 | 0 |
| K832055 | EMIT ASSAY AND TOBRAMYCIN | Syva Co. | 1983-08-08 | 42 | 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