U.S. FEDRegulation
FDA classifies hyperoxia monitor adjunct to pulse oximetry as class II device
The Food and Drug Administration classified the hyperoxia monitoring device adjunct to pulse oximetry into class II with special controls. FDA determined that the classification will provide reasonable assurance of the device's safety and effectiveness. The agency said the action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens. The order is effective October 6, 2026; the classification was applicable October 12, 2023.
Key points
- Hyperoxia monitoring device adjunct to pulse oximetry classified into class II.Federal Register
- Special controls identified in the order join the codified classification language.Federal Register
- FDA found class II will reasonably assure the device's safety and effectiveness.Federal Register
- Order effective October 6, 2026; classification applicable October 12, 2023.Federal Register
- The final order was published at 91 FR 63491 (FR Doc. 2026-20441).Federal Register
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RegulationU.S.FDA Final Order: Classification of Hyperoxia Monitoring Device Adjunct to Pulse Oximetry (Class II)HealthcareFor practitionersFor governance