Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CAR · 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) |
|---|---|---|---|---|---|
| K920740 | EPISENSOR PLUS | Industrias Palex C/O Dma Med-Chem Corp. | 1994-03-07 | 747 | 0 |
| K926066 | BION MUMPS-G ANTIBODY TEST SYSTEM | Bion Ent., Ltd. | 1993-06-15 | 196 | 1 |
| K915577 | IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE | Impra, Inc. | 1992-03-11 | 89 | 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