Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
DGP · 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) |
|---|---|---|---|---|---|
| K931224 | VIDAS TOTAL IGE (IGE) ASSAY | Biomerieux Vitek, Inc. | 1993-05-20 | 71 | 0 |
| K863327 | IMMPULSE IGE ASSAY REAGENTS | Sclavo, Inc. | 1986-12-03 | 98 | 0 |
| K842749 | FIAX TOTAL IGE TEST KIT | Intl. Diagnostic Technology | 1984-08-28 | 46 | 0 |
| K842969 | ALLERGENETICS ALLER-SPECIFIC IGE SERUM | Allergenetics | 1984-08-28 | 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