Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fudakang 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) |
|---|---|---|---|---|---|
| K172121 | Digital Thermometer | Fudakang Industrial Co., Ltd. | 2018-06-07 | 329 | 0 |
| K160308 | Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) | Fudakang Industrial Co., Ltd. | 2016-07-15 | 162 | 0 |
| K150430 | Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor | Fudakang Industrial Co., Ltd. | 2015-04-17 | 57 | 0 |
| K111703 | INFRARED EAR THEROMETER | Fudakang Industrial Co., Ltd. | 2012-03-29 | 286 | 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