Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Famidoc Technology Company Limited · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233192 | Wireless Smart Thermometer | Famidoc Technology Company Limited | 2024-04-05 | 190 | 0 |
| K222887 | Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pr | Famidoc Technology Company Limited | 2023-04-10 | 199 | 0 |
| K191673 | Upper Arm Blood Pressure Monitor | Famidoc Technology Company Limited | 2019-11-27 | 156 | 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