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FDA Warns on Unauthorized Blood Pressure Devices: What Consumers Should Check FDA

On September 16, 2025, the U.S. Food and Drug Administration (FDA) issued a safety communication warning consumers against using blood pressure measuring devices that have not been authorized by the FDA. The FDA explicitly stated that such devices, including blood pressure software features embedded in smartwatches and smart rings, have not undergone FDA review for safety and effectiveness. Inaccurate readings could lead users to delay seeking medical care, potentially resulting in serious consequences such as stroke or heart attack.

Key FDA Recommendations

In its communication, the FDA advises consumers to search for product code DXN in the 510(k) database to verify whether a specific blood pressure measuring device has received FDA authorization. Only devices that have passed 510(k) review and obtained authorization may legally be marketed in the United States as blood pressure measuring medical devices.

This communication was prompted by the growing number of consumer wearable devices on the market claiming blood pressure measurement capabilities, many of which have not gone through the medical device approval process. The FDA’s action aims to help consumers distinguish between “health monitoring features” and “medical diagnostic functions.” Importantly, the FDA’s warning targets devices that claim blood pressure measurement capability without authorization, not all wearable health products.

How Consumers Should Evaluate

Faced with a wide variety of blood pressure-related products, consumers can consider the following approach:

  • Distinguish intended use: If a product claims it can be used to diagnose, treat, or monitor conditions such as hypertension, it should have obtained FDA 510(k) authorization. Products making such claims without authorization carry compliance risks, and consumers should exercise caution.
  • Verify authorization status: Searching product code DXN in the FDA 510(k) database can confirm whether a specific device appears on the authorized list. This is a publicly accessible database that consumers can search independently.
  • Interpret health data rationally: Data provided by health monitoring devices that lack medical device authorization should serve only as lifestyle references and should not form the basis for medical decisions. Even if data shows abnormalities, confirmation through proper medical channels is recommended.

Important Disclaimer: The Smart Blood Glucose Meter GL1, Smart Electronic Blood Pressure Monitor BM1, Smart Body Fat Scale B1, Smart Band H1, and Smart Band H2 sold on this site are not medical devices. They are not intended for diagnosis or treatment of any disease. Data collected by these products is provided solely for general wellness and lifestyle reference purposes. If you feel unwell, please consult a healthcare professional. These products have not received FDA 510(k) authorization and must not be used as substitutes for professional medical equipment. For specific product information, please refer to the product detail pages. Compliance and safety details are available on our Product Compliance and Safety page.

Information current as of September 2026. Please refer to official sources for the latest updates.

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