Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
GMS · 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) |
|---|---|---|---|---|---|
| K853122 | IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPED | Immuno-Products Industries | 1985-09-19 | 56 | 0 |
| K843613 | FLUORESCENT TREPONEMEL ANTIBODY-ABSORB | Immuno-Products Industries | 1984-10-31 | 51 | 0 |
| K781403 | FTA-ABS TEST SYSTEM | Zeus Scientific, Inc. | 1978-08-21 | 6 | 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