Is Dream Sock® FDA-cleared? 

Yes! Dream Sock is the first FDA-cleared, over-the-counter infant monitoring device, and the only one available on the market today. The safety and well-being of babies has always been our top priority. We’re proud to offer a solution that is both trusted and proven to meet the FDA's rigorous safety and effectiveness standards—providing families with the peace of mind they deserve.

What's the difference between FDA clearance and FDA approval?

FDA clearance means the product has been reviewed by the FDA and found to be safe and effective for its intended use. This is the process Dream Sock went through — making it the first FDA-cleared smart baby monitor with live health readings and notifications for healthy infants at home. 

FDA approval is a designation typically used for drugs and high-risk medical devices. It involves a different and more extensive review process. So while both terms involve FDA review, clearance applies to products like Dream Sock that go through a different, but still rigorous, safety and accuracy evaluation. FDA clearance still means your baby’s safety is supported by trusted science and clinical review, which is what matters most.

Why does FDA clearance matter?

Yesterday, September 16, 2025, the FDA issued an official safety communication cautioning families against the use of unauthorized infant monitors that claim to track vital signs, but have not been reviewed for safety or effectiveness.

Dream Sock is the first FDA-cleared, over-the-counter infant monitoring device, and the only one available on the market today. FDA clearance means Dream Sock underwent rigorous clinical testing in both home and hospital environments and was proven to be as accurate as medical-grade pulse oximeters labeled for use in infants. While it isn’t a replacement for medical care, it gives parents trustworthy, real-time insights into their baby’s well-being.

You deserve clear, accurate information when it comes to their baby’s health and safety. While some devices on the market may now be under scrutiny, Owlet is proud to stand apart. For more information, you can view the FDA’s safety communication here.

Where can I find the Owlet Dream Sock classification?

The Owlet Dream Sock De Novo classification can be found here.