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Andon Medical co., LTD: FDA-registered device maker in Tianjin, China, 3 510(k) clearances

Name: Andon Medical co., LTD FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Andon Medical co., LTD is registered with the FDA (registration 3008573045) in Tianjin, China. It lists 17 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 12, 2025. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3008573045
Address: No.26 Hangyu Road, Tianjin Airport Economic Area Tianjin, Tianjin, 300381, China, Tianjin, China, 300381
Owner or operator: ANDON MEDICAL CO.,LTD (10033742)
Roles: Contract manufacturer, Manufacturer
First device listed: August 5, 2014
Registered through: 2027
Brand names listed: AG-607 Blood Glucose Monitoring System, AG-607 Multi Blood Glucose Monitoring System, ARM BLOOD PRESSURE MONITOR (model: KD-5920TL), Best Choice (model: 41-553), CVS COVID-19&Flu A/B&RSV Antigen Test (model: ICR-3000), Care One (model: 67-553), Discount Drug (model: 71-553), Discount Drug (model: 71-554) and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Body Composition, Exempt	PUH	2	Contract manufacturer	accessdata.fda.gov
Blood Pressure Cuff	DXQ	2	Contract manufacturer	accessdata.fda.gov
Clinical Electronic Thermometer	SDV	2	Contract manufacturer	accessdata.fda.gov
Coronavirus Antigen Detection Test System.	QKP	N	Manufacturer	accessdata.fda.gov
Covid-19 Multi-Analyte Antigen Device	QMN	N	Manufacturer	accessdata.fda.gov
Glucose Dehydrogenase, Glucose	LFR	2	Contract manufacturer	accessdata.fda.gov
Irrigator, Powered Nasal	KMA	1	Contract manufacturer	accessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The Counter	LCX	2	Contract manufacturer	accessdata.fda.gov
Multi-Analyte Respiratory Virus Antigen Detection Test	SCA	2	Manufacturer	accessdata.fda.gov
Over-The-Counter Covid-19 Antigen Test	QYT	2	Manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Contract manufacturer	accessdata.fda.gov
Oximeter, Infrared, Sporting, Aviation	OCH	2	Contract manufacturer	accessdata.fda.gov
Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch	OSG	2	Contract manufacturer	accessdata.fda.gov
Stimulator, Electrical, Transcutaneous, For Arthritis	NYN	2	Contract manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Contract manufacturer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Contract manufacturer	accessdata.fda.gov
System, Test, Blood Glucose, Over The Counter	NBW	2	Contract manufacturer	accessdata.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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 12, 2025	K251092	iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro	SCA	Substantially Equivalent	Ihealth Labs, Inc.	accessdata.fda.gov
December 12, 2025	K251085	iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro	SCA	Substantially Equivalent	Ihealth Labs, Inc.	accessdata.fda.gov
May 31, 2024	K233842	iHealth COVID-19 Antigen Rapid Test	QYT	Substantially Equivalent	Ihealth Labs, Inc.	accessdata.fda.gov

Compare with other makers

Updated December 12, 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.