Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Meditec Co., 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) |
|---|---|---|---|---|---|
| K041789 | NONINVASIVE BLOOD PRESSURE MONITOR, MODELS MD-880B AND MD-90 | Meditec Co., Ltd. | 2004-07-15 | 13 | 0 |
| K002655 | DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-550 | Meditec Co., Ltd. | 2000-09-06 | 12 | 0 |
| K992328 | FUZZY AUTOMATIC BLOOD PRESSURE MONITOR MODELS MD-750, MD-770 | Meditec Co., Ltd. | 1999-07-21 | 9 | 0 |
| K990380 | (1) DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-250; (2) FULLY | Meditec Co., Ltd. | 1999-02-22 | 14 | 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