Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Taihao Medical, 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) |
|---|---|---|---|---|---|
| K210670 | BU-CAD | Taihao Medical, Inc. | 2021-12-21 | 291 | 0 |
| K171709 | BR-FHUS Viewer 1.0 | Taihao Medical, Inc. | 2017-10-20 | 134 | 0 |
| K171309 | BR-FHUS Navigation 1.0 | Taihao Medical, Inc. | 2017-09-29 | 149 | 0 |
| K151075 | BR-ABVS Viewer 1.0 | Taihao Medical, Inc. | 2016-01-15 | 268 | 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