Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mindray DS USA, 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) |
|---|---|---|---|---|---|
| K132026 | V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21 | Mindray DS USA, Inc. | 2013-12-20 | 172 | 1 |
| K102471 | AS3700 ANESTHSIA DELIVERY SYSTEM | Mindray DS USA, Inc. | 2011-02-11 | 165 | 2 |
| K102004 | ENDEAVOUR MONITORING SYSTEM | Mindray DS USA, Inc. | 2010-09-10 | 57 | 3 |
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