The smart ring race just gained a new seal of credibility. RingConn, the health-focused wearable maker founded in 2021, announced on October 10 that its Smart Ring has received 510(k) clearance from the U.S. Food and Drug Administration for non-invasive blood oxygen (SpO2) measurement (Clearance No. K260490).
The clearance means RingConn's ring has undergone FDA regulatory review and was found substantially equivalent to legally marketed predicate devices for measuring blood oxygen non-invasively. A quick note on what 510(k) clearance actually means: it is not the same as FDA "approval" — it is a regulatory pathway in which the FDA determines a device is substantially equivalent to an already-cleared predicate device. Still, it is a meaningful bar, and it gives RingConn compliance assurance as it expands deeper into the U.S. healthcare and wellness market.
SpO2 — the percentage of oxygen-saturated hemoglobin in the blood — is a key indicator of respiratory and circulatory function, and continuous, convenient monitoring matters for everyday health tracking as well as athletic and sleep use cases. Under the hood, the ring uses PPG (photoplethysmography) sensor technology — the same optical approach found in smartwatches — to estimate blood oxygen through the skin. The company says it continues to conduct clinical research related to blood oxygen monitoring to build a stronger data foundation for clinical validation.
This is a notable milestone in a category still working through growing pains. Smart rings live or die on sensor accuracy in a tiny form factor, and an FDA-reviewed SpO2 claim puts RingConn in rare company among ring makers — a space where Oura, Samsung, and others are circling. To date, RingConn says it holds international certifications including EU CE, U.S. FCC, Japan MIC, UK UKCA, and Australia RCM, and sells in more than 190 countries and regions.
The broader trend is unmistakable: health sensing is moving off the wrist and onto the finger, and regulators are paying attention. Whether you're tracking sleep, training, or just want overnight SpO2 readings without a watch band, the ring form factor keeps gaining ground. RingConn's clearance won't settle the accuracy debates on its own, but it's one more sign the smart ring category is growing up.