Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Kangfu Medical Equipment Factory · 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) |
|---|---|---|---|---|---|
| K201600 | Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24 | Kangfu Medical Equipment Factory | 2021-12-10 | 546 | 0 |
| K182652 | COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-0 | Kangfu Medical Equipment Factory | 2018-11-20 | 57 | 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