Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Metatech 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) |
|---|---|---|---|---|---|
| K033077 | EASYTEM DUO, FOREHEAD/EAR THERMOMETER, MODEL BT-021 | Metatech Co., Ltd. | 2004-04-30 | 214 | 0 |
| K033082 | 9 SECOND DIGITAL THERMOMETER, MODEL BT-S09 | Metatech Co., Ltd. | 2003-12-03 | 65 | 0 |
| K020520 | EASYTEM EAR THERMOMETER, MODEL BT-020 | Metatech Co., Ltd. | 2002-08-06 | 168 | 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