Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
LRF · 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) |
|---|---|---|---|---|---|
| K883118 | ON THE SPOT CANDIDASURE | Medi-Tech, Inc. | 1988-09-30 | 67 | 0 |
| K863499 | CANDIDATE(R) SUPER | Mercia Diagnostics , Ltd. | 1987-03-19 | 191 | 0 |
| K843286 | EI-CANDIDA ENZYME IMMUNOASSAY EI1001 | Immuno-Mycologics, Inc. | 1984-10-01 | 41 | 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