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# Masimo O3 Regional Oximetry for Neonatal/Infants
- URL: https://www.fdaweb.com/masimo-o3-regional-oximetry-for-neonatal-infants/
- Published: 2019-06-10T12:00:00.000Z
- Updated: 2026-09-15T01:31:42.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144296

FDA has cleared a Masimo 510(k) for its O3 Regional Oximetry for use on neonatal and infant patients. The device is intended to help clinicians monitor cerebral oxygenation in situations where peripheral pulse oximetry alone may not be fully indicative of the oxygen in the brain, Masimo says The device uses near-infrared spectroscopy to monitor the regional hemoglobin oxygen saturation of blood on both sides of the brain. O3 sensors are now available in three sizes — adult (greater-than 40 kg), pediatric (greater than 5 kg) and infant and neonatal (less than 10 kg). Additionally, Masimo says the device integrates with the company’s Root Patient Monitoring and Connectivity Platform.