# Hangzhou Hua'An Medical & Health Instruments Co.,

- Location (FDA's records): Hangzhou, CN
- FDA decisions: 10 (2003–2018): 10 510(k) clearances
- Names in FDA's records: Hangzhou Hua'An Medical & Health Instruments Co., (7); Hangzhou Hua'An Medical&Health Instruments Co.,Ltd (3)
- Product codes: FLL (8), DXN (2)
- 510(k) review time since 2016: median 112 days, against 174 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Changshan Estar Electronics Co., Ltd.: 1 (https://510kreport.com/company/changshan-estar-electronics)
- Sejoy Electronics & Instruments Co., Ltd.: 1 (https://510kreport.com/company/sejoy-electronics-instruments)

## Its most-cited devices
- K041694: Digital Flexible Thermometer, Basic Digital Thermometer, Ditital Pacifier Thermometer (2004), cited by 2

## Recent decisions
- K172870: Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J (Feb 13, 2018)
- K172861: Digital thermometer (with disposable thermometer cover) (Dec 19, 2017)
- K160999: Infra-red forehead thermometer (Aug 1, 2016)
- K122912: Digital Thermometer (with Disposable Thermometer Cover) (Nov 7, 2012)
- K092447: Digital Thermometer (with Disposable Thermometer Cover), DT Series (Jan 7, 2010)
- K092514: Upperarm Digital Blood Pressure Monitor, Model: MB-300 Series (Dec 4, 2009)
- K041693: Wrist Digital Blood Pressure Monitor (Digital Sphygmomanometer), MW-300 Series (Dec 2, 2004)
- K041694: Digital Flexible Thermometer, Basic Digital Thermometer, Ditital Pacifier Thermometer (Sep 13, 2004)

Source page: https://510kreport.com/company/hangzhou-hua-an-medical-health-instruments