RingConn Smart Ring Gets FDA 510(k) Clearance for Blood Oxygen Measurement
RingConn's Smart Ring has received 510(k) clearance from the U.S. Food and Drug Administration for non-invasive blood oxygen (SpO2) measurement. Shenzhen Ninenovo Technology Limited, the ring's parent company, announced the clearance under number K260490.
- RingConn's Smart Ring received FDA 510(k) clearance for non-invasive blood oxygen (SpO2) measurement, No. K260490.
- The FDA found the device substantially equivalent to legally marketed predicate devices, according to parent company Shenzhen Ninenovo.
- The ring uses PPG sensor technology for SpO2 measurement, per the company.
- RingConn says clinical research on blood oxygen monitoring is continuing.
- The company says the product is available in more than 190 countries and regions.
What the FDA clearance covers
According to Shenzhen Ninenovo Technology Limited, the FDA reviewed RingConn's Smart Ring and determined it to be substantially equivalent to legally marketed predicate devices for non-invasive measurement of blood oxygen (SpO2). The clearance is listed as No. K260490.
The company calls the clearance "a significant milestone" for RingConn in the space of FDA-cleared wearable health devices. It says the decision provides compliance assurance for RingConn's expansion into the U.S. healthcare and wellness market, and strengthens its technical foundation in health monitoring applications for smart rings.
How the ring measures blood oxygen
The company describes blood oxygen (SpO2) as a key physiological indicator of respiratory and circulatory function. It argues that continuous and convenient monitoring matters for daily health tracking and for keeping an eye on physiological condition.
According to RingConn, the ring uses PPG sensor technology and other advancements to carry out non-invasive SpO2 measurement. The company says this brings professional-grade monitoring capabilities into an everyday wearable form factor.
RingConn also says it continues to conduct clinical research related to blood oxygen monitoring, with the aim of building a solid data foundation for clinical validation of the product.
Existing certifications and reach
Besides the FDA clearance, RingConn says it has obtained several international certifications: EU CE, U.S. FCC, Japan MIC, UK UKCA and Australia RCM. According to the company, the product is available in more than 190 countries and regions worldwide.
RingConn was established in 2021. It describes itself as a user-centric company that aims to provide professional, continuous and thoughtful health monitoring products and services.
What it means for users and the market
For users in the United States, the clearance means the ring's SpO2 measurement has passed FDA regulatory review as substantially equivalent to existing legally marketed devices. For RingConn, the company frames it as a basis for growing in the U.S. healthcare and wellness market.
The announcement does not give details on pricing, new features or availability changes tied to the clearance, and the company says its clinical research on blood oxygen monitoring is still ongoing.
