Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tripath Imaging, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K062428 | VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS | Tripath Imaging, Inc. | 2006-09-29 | 42 | 0 |
| K053520 | VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67 | Tripath Imaging, Inc. | 2006-04-11 | 113 | 0 |
| K051282 | VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU | Tripath Imaging, Inc. | 2005-08-16 | 91 | 0 |
| K050012 | VENTANA IMAGE ANALYSIS SYSTEM | Tripath Imaging, Inc. | 2005-05-06 | 123 | 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