Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bioimagene, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K092333 | PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67 | Bioimagene, Inc. | 2010-10-27 | 449 | 0 |
| K080910 | PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & | Bioimagene, Inc. | 2009-02-04 | 309 | 0 |
| K062756 | PATHIAM IMAGING SOFTWARE FOR HER2/NEU | Bioimagene, Inc. | 2007-02-20 | 159 | 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