When it comes to caring for your little one, peace of mind is everything. That’s why we’re proud to share that Owlet Dream Sock® is the first FDA-cleared, over-the-counter infant monitoring device, and the only one available on the US 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.

But what does FDA clearance actually mean—and why does it matter? Let’s break it down.

Why FDA Clearance Matters

To receive FDA clearance, Dream Sock underwent extensive clinical testing in both home and hospital settings. It was proven to be as accurate as medical-grade pulse oximeters that are labeled for infant use. That’s a powerful assurance for parents and caregivers who want the best for their baby.

Our team worked hand-in-hand with medical experts to ensure the technology met the highest standards. The result? A first-of-its-kind smart baby monitor that empowers parents with real-time information on their baby’s pulse rate, oxygen, and sleep patterns—all from the comfort of their home.

With Dream Sock, you're not just getting a monitor—you’re getting a clinically-proven tool that helps you better understand your baby’s well-being and feel more confident in your care.

FDA Clearance vs. FDA Approval: What’s the Difference?

Both FDA clearance and FDA approval involve review by the U.S. Food and Drug Administration, but they apply to different types of products:

- FDA approval is a more extensive process that is typically reserved for drugs and high-risk medical devices

- FDA clearance—which applies to Dream Sock—means that a product has been rigorously tested and reviewed for safety and effectiveness for its intended use. 

So while the pathways are different, the commitment to safety and accuracy is the same. FDA clearance means the safety and performance of Dream Sock for its intended use are supported by trusted science and FDA review, which is what matters most.

A New Warning from the FDA

On September 16, 2025, the FDA issued a public safety communication urging families to be cautious about unauthorized infant monitoring devices 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. This sets Dream Sock apart from other devices that have not undergone FDA review. For more information, you can view the FDA’s safety communication here.