Skip to content
Product safetyFDAUnited StatesImports

Medical Devices; Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use

9 October 2026

In plain English

FDA classifies the infant pulse rate and oxygen saturation monitor for over-the-counter use into class II with special controls, as set out in this order.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
9 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 infant pulse rate and oxygen saturation monitor for over-the-counter use 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 infant pulse rate and oxygen saturation monitor for over-the-counter use. We are taking this action because we have determined that classifying the device into class II will provide a
The full text is at the source

Olive tells you which of these hit your products.

Olive reads every change like these against your own products, codes and trade lanes, whether you import, export or both, and drafts the update to your compliance program for your approval. Nothing changes without you.

Get startedLive demo

Olivra lists official notices for information only. It is not legal advice, and Olive is not a lawyer or a licensed customs broker. The official text at the source is what counts.

More from FDA

See everything Olive monitors