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Product safetyFDAUnited StatesImports

Medical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse Oximetry

6 October 2026

In plain English

FDA classifies the hyperoxia monitoring device adjunct to pulse oximetry as a class II medical device subject to identified special controls.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
6 October 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

The Food and Drug Administration (FDA) is classifying the hyperoxia monitoring device adjunct to pulse oximetry into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the hyperoxia monitoring device adjunct to pulse oximetry. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and
The full text is at the source

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