Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fudakang Industries Co., Ltd. · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K152640 | Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41 | Fudakang Industries Co., Ltd. | 2016-03-28 | 195 | 0 |
| K101387 | DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CN | Fudakang Industries Co., Ltd. | 2010-08-03 | 77 | 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