# Andon Health Co, Ltd.

- Location (FDA's records): Tianjin, CN
- FDA decisions: 92 (2008–2025): 92 510(k) clearances
- Product codes: DXN (68), NBW (8), FLL (5), DQA (2), NUH (2), MNW (1), LCX (1), FXX (1), DXQ (1), DSH (1), MWI (1), DPS (1)
- 510(k) review time since 2016: median 157 days, against 184 for FDA's reviews in the same codes and years (17 of 31 faster)
- Predicates its devices cite: 106 (73 its own); citations of its devices by later devices: 95 (73 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Kodon (Tianjin)Electronic&Electrical Apparatus Co.,: 15 (https://510kreport.com/company/kodon-tianjin-electronic-electrical-apparatus)
- Andon Medical Co., Ltd.: 3 (https://510kreport.com/company/andon-medical)
- Guangzhou Berrcom Medical Device Co., Ltd.: 2 (https://510kreport.com/company/guangzhou-berrcom-medical-device)
- Lifescan, Inc.: 1 (https://510kreport.com/company/lifescan)
- Watermark Medical: 1 (https://510kreport.com/company/watermark-medical)
- Chattem, Inc.: 1 (https://510kreport.com/company/chattem)
- Easymed Instruments Co., Ltd.: 1 (https://510kreport.com/company/easymed-instruments)
- Kaz USA, Inc., A Helen of Troy Company: 1 (https://510kreport.com/company/kaz-usa-a-helen-of-troy)

## Firms that cite its devices most
- Andon Medical Co., Ltd.: 5 (https://510kreport.com/company/andon-medical)
- Withings: 2 (https://510kreport.com/company/withings)
- Suzhou Minhua Medical Apparatus Supplies Co., Ltd.: 2 (https://510kreport.com/company/suzhou-minhua-medical-apparatus-supplies)
- Microlife Corp.: 1 (https://510kreport.com/company/microlife)
- Famidoc Technology Co., Ltd.: 1 (https://510kreport.com/company/famidoc-technology)
- Adon Health Co., Ltd.: 1 (https://510kreport.com/company/adon-health)
- Globalcare Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/globalcare-medical-technology)
- Qardio, Inc.: 1 (https://510kreport.com/company/qardio)

## Its most-cited devices
- K102939: Fully Automatic Electronic Blood Pressure Monitor Model KD-931 (2011), cited by 6
- K120672: KD-936 Fully Automatic Wireless Blood Pressure Monitor (2012), cited by 6
- K083317: Fully Automatic Electronic Blood Pressure Monitor, Model KD-5902 (2009), cited by 5
- K102906: Fully Automatic Electronic Blood Pressure Monitor (2010), cited by 5
- K080319: KD-591 Fully Automatic Electronic Blood Pressure Monitor (2008), cited by 4
- K141984: Fully Automatic Electronic Blood Pressure Monitor (2015), cited by 4

## Recent decisions
- K251113: iHealth Compare Wireless Blood Pressure Monitor (BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor (BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor (BP-300V);iHealth Wireless Blood Pressure Monitor (BPX1);iHealth Blood Pressure Monitor (KD-595);iHealth Track Pro Connected Blood Pressure Monitor (KN-550LT);Semi Automatic Blood Pressure Monitor (KD-388N);Arm Blood Pressure Monitor (KD-553);Arm Blood Pressure Monitor (KD-557BR);Arm Blood Pressure Monitor (KD-558);Arm Blood Pr (Aug 4, 2025)
- K241394: iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip (Dec 20, 2024)
- K234041: Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS) (Apr 22, 2024)
- K222869: Arm Blood Pressure Monitor (Feb 15, 2023)
- K222867: AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) (Dec 21, 2022)
- K212598: iHealth infrared Ear thermometer PT5 (Jan 28, 2022)
- K210768: Wrist Blood Pressure Monitor, Blood Pressure Monitor (Jul 30, 2021)
- K210770: Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor (Jul 29, 2021)

Source page: https://510kreport.com/company/andon-health