Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mesure Technology Co., Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
25 daysmedian FDA review time
568 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K080981 | EAR THERMOMETER, MODELS ST66 AND ST67 | Mesure Technology Co., Ltd. | 2008-05-02 | 25 | 0 |
| K071019 | DIGITAL CLINICAL THERMOMETER/MODELS ST8C SERIES | Mesure Technology Co., Ltd. | 2007-04-27 | 17 | 0 |
| K063542 | WIRELESS TEMPERATURE MONITOR / MODELS ST323C AND ST323F. | Mesure Technology Co., Ltd. | 2007-04-10 | 137 | 0 |
| K050303 | 5 SEC DIGITAL CLINICAL THERMOMETER, MODELS ST8630X, ST8640X, | Mesure Technology Co., Ltd. | 2005-02-25 | 17 | 0 |
| K042627 | EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65 | Mesure Technology Co., Ltd. | 2004-10-18 | 21 | 0 |
| K042013 | DIGITAL CLINICAL THERMOMETER, MODELS ST-8A3C AND ST-8A3F | Mesure Technology Co., Ltd. | 2004-09-08 | 43 | 0 |
| K023956 | THERMOMETER MODELS ST313C/F, ST314C/F, ST323C/F, ST324C/F, S | Mesure Technology Co., Ltd. | 2004-06-17 | 568 | 0 |
| K041056 | 10-SECOND DIGITAL THERMOMETER, MODELS ST87, ST89, ST80, ST88 | Mesure Technology Co., Ltd. | 2004-05-12 | 19 | 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