Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MLE · 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) |
|---|---|---|---|---|---|
| K010558 | QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA | Inova Diagnostics, Inc. | 2001-04-03 | 36 | 0 |
| K991942 | AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA | Cogent Diagnotics , Ltd. | 1999-08-24 | 76 | 0 |
| K951206 | VARELISA PARIETAL CELL ANTIBODIES | Elias U.S.A., Inc. | 1995-04-17 | 31 | 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