Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LLA · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K913467 | TOXOGEN | Biokit USA, Inc. | 1993-01-11 | 525 | 0 |
| K890048 | QUIK-DOT TOXOPLASMOSIS | Ampcor, Inc. | 1989-06-09 | 154 | 0 |
| K850768 | TOXOSCAN CARD TEST KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-05-20 | 84 | 0 |
| K831930 | TOXO-SCREEN DA TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-09-26 | 103 | 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