FDA applicant
Hangzhou Hua'An Medical & Health Instruments Co.,
FDA records 10 decisions for Hangzhou Hua'An Medical & Health Instruments Co., (Hangzhou, CN) from 2003 to 2018: 10 510(k) clearances. Most are in product codes FLL (Continuous Measurement Thermometer) and DXN (System, Measurement, Blood-Pressure…). Since 2016 its 510(k)s took a median of 112 days from receipt to decision, against 174 for FDA’s reviews in the same codes and years. No recall is linked to its devices.
FDA’s records also spell it “Hangzhou Hua'An Medical&Health Instruments Co.,Ltd”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Hangzhou Hua'An Medical & Health Instruments Co.,’s devices, and how often a recall has named them.
FDA decisions per year
1in 2018
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
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