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Data / Medical devices / China / Andon Health Co., Ltd

Andon Health Co., Ltd: FDA-registered device maker in Tianjin, China, 26 510(k) clearances

Andon Health Co., Ltd is registered with the FDA (registration 3003741676) in Tianjin, China. It lists 18 device types. The FDA files 26 510(k) clearances under its listings, the newest dated August 4, 2025. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Andon Health Co., Ltd
FDA registration number
3003741676
Address
No. 3 Jin Ping Street,Ya An Road, NANKAI DISTRICT, Tianjin, China, 300190
Owner or operator
ANDON HEALTH CO.,LTD (9055208)
Roles
Contract manufacturer, Exporter to the US, Manufacturer, Specification developer
First device listed
January 31, 2009
Registered through
2027
Brand names listed
AG-607 Multi Blood Glucose Monitoring System, ARM BLOOD PRESSURE MONITOR (model: KD-5920TL), Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor(KD-552), AtCor Medical Pty Ltd – CONNEQT PULSE, Best Choice (model: 41-553), Care One (model: 67-553), Discount Drug (model: 71-553), Discount Drug (model: 71-554) and more

Devices it lists

DeviceProduct codeClassRoleSource
Analyzer, Body CompositionMNW2Manufactureraccessdata.fda.gov
Analyzer, Body Composition, ExemptPUH2Exporter to the US, Specification developeraccessdata.fda.gov
Blood Pressure CuffDXQ2Exporter to the US, Specification developeraccessdata.fda.gov
Clinical Electronic ThermometerSDV2Specification developeraccessdata.fda.gov
Computer, Blood-PressureDSK2Contract manufactureraccessdata.fda.gov
Glucose Dehydrogenase, GlucoseLFR2Exporter to the US, Specification developeraccessdata.fda.gov
Hearing Aid, Air-Conduction With Wireless Technology, Over The CounterQUG2Manufactureraccessdata.fda.gov
Irrigator, Powered NasalKMA1Specification developeraccessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The CounterLCX2Specification developeraccessdata.fda.gov
Multiple Use Blood Lancet For Single Patient Use OnlyQRL2Exporter to the USaccessdata.fda.gov
OximeterDQA2Exporter to the US, Specification developeraccessdata.fda.gov
Oximeter, Infrared, Sporting, AviationOCH2Exporter to the US, Specification developeraccessdata.fda.gov
Piezo-Electric Stimulator For Relief Of Mosquito Bite ItchOSG2Specification developeraccessdata.fda.gov
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention FeatureQRK2Exporter to the USaccessdata.fda.gov
Stimulator, Electrical, Transcutaneous, For ArthritisNYN2Specification developeraccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-CounterNUH2Specification developeraccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Contract manufacturer, Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
System, Test, Blood Glucose, Over The CounterNBW2Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 4, 2025K251113iHealth 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 PrDXNSubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov
December 20, 2024K241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripLCXSubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov
April 22, 2024K234041Fully 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)DXNSubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov
December 21, 2022K222867AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)NUHSubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov
September 7, 2022K222034RightLance Blood Lancing SystemQRLSubstantially EquivalentBeijing Ruicheng Medical Supplies Co., Ltd.accessdata.fda.gov
July 30, 2021K210768Wrist Blood Pressure Monitor, Blood Pressure MonitorDXNSubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov
July 29, 2021K210770Arm Blood Pressure Monitor, Wireless Blood Pressure MonitorDXNSubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov
June 4, 2019K183535Fully Automatic Electronic Blood Pressure MonitorDXNSubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov
May 16, 2019K183534Fully Automatic Electronic Blood Pressure MonitorDXNSubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov
February 1, 2019K181070iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)NBWSubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov
August 1, 2017K171062BP5S Wireless Blood Pressure MonitorDXNSubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov
May 11, 2017K163276Fully Automatic Electronic Blood Pressure MonitorDXNSubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov
February 16, 2017K153561AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring SystemNBWSubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov
February 8, 2017K162915Fully Automatic Electronic Blood Pressure MonitorDXNSubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov
February 1, 2017K162144iHealth Wireless Blood Pressure MonitorDXNSubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov
February 2, 2016K160014iHealth Track Blood Pressure MonitorDXNSubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov
September 24, 2015K152003iHealth BP3L Wireless Blood Pressure MonitorDXNSubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov
September 23, 2015K152379iHealth View BP7S Wireless Blood Pressure Wrist MonitorDXNSubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov
September 8, 2015K151460Fully Automatic Electronic Blood Pressure MonitorDXNSubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov
April 29, 2015K141984FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITORDXNSubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov
March 4, 2014K133117ANDON BLOOD PRESSURE CUFFDXQSubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov
September 11, 2013K131111IHEALTH FINGERTIP PULSE OXIMETERDQASubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov
July 19, 2013K131203IHEALTH CLOUDDXNSubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov
March 21, 2013K122098APPS-HEALTH01DXNSubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov
July 30, 2009K092045FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-738 AND KD-739DXNSubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov
January 29, 2009K083318FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5904DXNSubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov

Compare with other makers

Updated August 4, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.