Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nam Tai , 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) |
|---|---|---|---|---|---|
| K873765 | FORTEC MI-100, MI-50 DIGITAL BLOOD PRESSURE METER | Nam Tai , Ltd. | 1987-10-09 | 23 | 0 |
| K872584 | FORTEC MI-306, MI-327 DIGITAL THERMOMETER | Nam Tai , Ltd. | 1987-07-27 | 26 | 0 |
| K853317 | FORTEC MI-305 & 306 DIGITAL THERMOMETER | Nam Tai , Ltd. | 1986-01-27 | 173 | 0 |
| K851873 | FORTEC MI-305 | Nam Tai , Ltd. | 1985-05-13 | 14 | 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