Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Hangzhou Hua'An Medical & Health Instruments Co., · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
163 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K122912 | DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER) | Hangzhou Hua'An Medical & Health Instruments Co., | 2012-11-07 | 47 | 0 |
| K092447 | DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT | Hangzhou Hua'An Medical & Health Instruments Co., | 2010-01-07 | 150 | 0 |
| K092514 | UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIE | Hangzhou Hua'An Medical & Health Instruments Co., | 2009-12-04 | 109 | 0 |
| K041693 | WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMET | Hangzhou Hua'An Medical & Health Instruments Co., | 2004-12-02 | 163 | 0 |
| K041692 | INFRARED EAR THERMOMETER, ET-100 SERIES | Hangzhou Hua'An Medical & Health Instruments Co., | 2004-09-13 | 83 | 0 |
| K041694 | DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DIT | Hangzhou Hua'An Medical & Health Instruments Co., | 2004-09-13 | 83 | 0 |
| K030361 | JASUN, MODELS DT-01F AND DT-11F | Hangzhou Hua'An Medical & Health Instruments Co., | 2003-02-21 | 18 | 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