Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hubdic Co., Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
180 daysmedian FDA review time
513 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K191978 | Fever Garde | Hubdic Co., Ltd. | 2020-12-18 | 513 | 0 |
| K130361 | THERMOFINDER; THERMOCARE | Hubdic Co., Ltd. | 2013-04-02 | 48 | 0 |
| K101912 | THE INFRARED FOREHEAD THERMOMETER, MODEL FS-300&301 | Hubdic Co., Ltd. | 2010-11-10 | 124 | 0 |
| K080636 | DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100 | Hubdic Co., Ltd. | 2009-02-13 | 344 | 0 |
| K043331 | DIGITAL FOREHEAD THERMOMETER, MODEL FS-100 | Hubdic Co., Ltd. | 2005-03-04 | 92 | 0 |
| K023412 | THERMO BUDDY, MODELS TB-100, TB-110, TB-120 | Hubdic Co., Ltd. | 2003-04-09 | 180 | 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