Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LHJ · 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) |
|---|---|---|---|---|---|
| K940557 | STAPHYTECT-OD | Unipath , Ltd. | 1994-07-28 | 171 | 0 |
| K842709 | IMMUSTAPH LATEX AGGLUTINATION KIT | Immucell Corp. | 1984-08-03 | 22 | 0 |
| K812181 | STAPHYLOCOCCAL PROTEIN A INSOLUBLE | Oxoid U.S.A., Inc. | 1981-08-25 | 22 | 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