RingConn Smart Ring Secures US FDA 510(k) Clearance for Non-Invasive Blood Oxygen Monitoring
12 October 2026 | Monday | News
Shenzhen Ninenovo Technology Limited, the parent company of RingConn, announced that its Smart Ring has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for non-invasive blood oxygen (SpO2) measurement (Clearance No. K260490).
This clearance marks a significant milestone for RingConn in the FDA-cleared wearable health device space. RingConn has undergone FDA regulatory review and has been determined to be substantially equivalent to legally marketed predicate devices for non-invasive measurement of blood oxygen (SpO2). This clearance provides compliance assurance for RingConn's expansion into the U.S. healthcare and wellness market, and further strengthens its technical foundation in health monitoring applications for smart rings.
Blood oxygen (SpO2) is a key physiological indicator of respiratory and circulatory function, and continuous, convenient blood oxygen monitoring is of great significance for daily health tracking and physiological condition monitoring. RingConn uses PPG sensor technology and other advancements to achieve non-invasive blood oxygen (SpO2) measurement, integrating professional-grade monitoring capabilities into an everyday wearable form factor. RingConn continues to conduct clinical research related to blood oxygen monitoring, building a solid data foundation for clinical validation of the product.
To date, RingConn has obtained multiple international authoritative certifications, including EU CE, U.S. FCC, Japan MIC, UK UKCA, and Australia RCM. The product is available in more than 190 countries and regions worldwide.
Most Read
- Can APAC Biomanufacturing Decarbonise Without Pricing Itself Out?
- The Algorithm on the GMP Floor: AI Promises a Smarter Plant. Regulators Demand the Audit Trail.
- APAC's Peptide-Capacity Gamble
- After the Rush: APAC's mRNA and Vaccine Capacity Hangover
- The Biosimilar Race: Factory to the World — or Stuck in the Copycat Economy?
- The Vein-to-Vein Problem: Can APAC's Cold Chain Carry Advanced Therapies?
- Vectors, Plasmids and the CGT Trap: APAC's Cell and Gene Therapy Ambitions Face an Upstream Bottleneck
- Can APAC Build Radioligand Therapy Before the Atoms Decay?
- The Great Biopharma Reset: 50 Developments That Changed Everything in H1 2026
- Beyond the Trial: Can Real-World Evidence Earn Regulatory Trust in APAC?
- Beyond the Obvious Giant: Where APAC's Clinical Trials Go Next
- The Frontier That Won’t Quite Arrive
Bio Jobs
- Sanofi Turns The Page As Belén Garijo Steps In And Paul Hudson Steps Out
- Global Survey Reveals Nearly 40% of Employees Facing Fertility Challenges Consider Leaving Their Jobs
- BioMed X and AbbVie Begin Global Search for Bold Neuroscience Talent To Decode the Biology of Anhedonia
- Thermo Fisher Expands Bengaluru R&D Centre to Advance Antibody Innovation and Strengthen India’s Life Sciences Ecosystem
- Accord Plasma (Intas Group) Acquires Prothya Biosolutions to Expand Global Plasma Capabilities
- ACG Announces $200 Million Investment to Establish First U.S. Capsule Manufacturing Facility in Atlanta
- AstraZeneca Invests $4.5 Billion to Build Advanced Manufacturing Facility in Virginia, Expanding U.S. Medicine Production
News
