Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Tianjin Empecs Medical Device 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) |
|---|---|---|---|---|---|
| K162564 | Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 | Tianjin Empecs Medical Device Co., Ltd. | 2017-06-07 | 266 | 0 |
| K152534 | Medisign MM1000 BT Blood Glucose Monitoring System, Medisign | Tianjin Empecs Medical Device Co., Ltd. | 2017-03-21 | 564 | 0 |
| K133260 | MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOO | Tianjin Empecs Medical Device Co., Ltd. | 2014-06-27 | 247 | 0 |
| K111456 | MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM | Tianjin Empecs Medical Device Co., Ltd. | 2012-02-28 | 279 | 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