Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Zen Strong Medical Technology Co., Ltd. · 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) |
|---|---|---|---|---|---|
| K090027 | BLOOD PRESSURE MONITOR, ZSBP-003/004/005/006/007/008 AND ZSB | Zen Strong Medical Technology Co., Ltd. | 2009-02-02 | 28 | 0 |
| K070578 | CLINICAL THERMOMETER/MODEL ZSDT-XXXX DIGITAL THERMOMETER AND | Zen Strong Medical Technology Co., Ltd. | 2007-07-11 | 132 | 0 |
| K070473 | BLOOD PRESSURE MONITOR, MODELS ZSBP-OXX AND ZSBP-1XX | Zen Strong Medical Technology Co., Ltd. | 2007-05-23 | 92 | 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