Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Hangzhou Hua'An Medical&Health Instruments Co.,Ltd · 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) |
|---|---|---|---|---|---|
| K172870 | Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, | Hangzhou Hua'An Medical&Health Instruments Co.,Ltd | 2018-02-13 | 146 | 0 |
| K172861 | Digital thermometer(with disposable thermometer cover) | Hangzhou Hua'An Medical&Health Instruments Co.,Ltd | 2017-12-19 | 90 | 0 |
| K160999 | Infra-red forehead thermometer | Hangzhou Hua'An Medical&Health Instruments Co.,Ltd | 2016-08-01 | 112 | 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