Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KQI · 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) |
|---|---|---|---|---|---|
| K880653 | HBF DILUENT | Helena Laboratories | 1988-04-21 | 64 | 0 |
| K812226 | HELENA HBF QUIPLATE CONTROL | Helena Laboratories | 1981-09-01 | 22 | 0 |
| K810475 | HELENA HEMOGLOBIN F CONTROLS | Helena Laboratories | 1981-03-26 | 31 | 0 |
| K791143 | SICKLE-CELL F TEST | Isolab, Inc. | 1979-07-17 | 29 | 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