Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rossmax Internationl , Ltd. · 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) |
|---|---|---|---|---|---|
| K053006 | ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II | Rossmax Internationl , Ltd. | 2006-02-03 | 100 | 0 |
| K020897 | ROSSMAX AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODELS B150 | Rossmax Internationl , Ltd. | 2002-08-06 | 140 | 0 |
| K010498 | WRISTWATCH BLOOD PRESSURE MONITOR A46 | Rossmax Internationl , Ltd. | 2001-03-20 | 27 | 0 |
| K010190 | WRISTWATCH BLOOD PRESSURE MONITOR, MODEL A43 | Rossmax Internationl , Ltd. | 2001-02-08 | 17 | 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