Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Duteck Industrial 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) |
|---|---|---|---|---|---|
| K132140 | DUTECK(MICHEALTH)DIGITAL CLINICAL THERMOMETER | Duteck Industrial Co., Ltd. | 2014-02-04 | 208 | 0 |
| K060642 | DUTECK BODY COMPOSITION ANALYZER | Duteck Industrial Co., Ltd. | 2006-06-07 | 89 | 0 |
| K021601 | MICHEALTH ET 1100/ET 1200 INFARED EAR THERMOMETER | Duteck Industrial Co., Ltd. | 2002-07-10 | 56 | 0 |
| K992327 | DUTECK DIGITAL CLINICAL THERMOMETER | Duteck Industrial Co., Ltd. | 1999-08-18 | 37 | 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