Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CEL · 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) |
|---|---|---|---|---|---|
| K905829 | DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS | Kamiya Biomedical Co. | 1991-01-30 | 30 | 0 |
| K884169 | DU PONT ANALYST THYROID ROTOR | The DU Pont Co. | 1989-01-24 | 112 | 0 |
| K801076 | WAKO PHOSPHOLIPIDS TEST | Wako Pure Chemical Industries, Ltd. | 1980-06-30 | 54 | 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