Baby Gear

Owlet sock on a baby foot, in a story about how the Owlet receives FDA approval

The Owlet Dream Sock Baby Monitor Is Now FDA-Cleared & Available

Here’s what that means for parents.

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Somewhere along the way, baby monitors got a whole lot smarter — sensing the temperature in baby’s room, and even checking their oxygen saturation and heart rate. Perhaps the most recognizable brand of smart baby monitors, Owlet, has received FDA clearance on its Dream Sock — the brand’s signature little blue sock, camera, and app-based monitor system — as well as the BabySat, their hospital-grade monitor (which requires a prescription). As of January 8, 2024, both models are now available for parents and babies to use at home. So, what does it mean for parents to choose a monitor that’s FDA-cleared, and will anything change with your Owlet if you already own one?

On Nov. 9, Owlet announced it received De Novo clearance from the U.S. Food and Drug Administration (FDA) for the Dream Sock, making it the first medical-grade pulse oximetry monitor available for anyone to buy. Other medical-grade monitors are available via prescription for infants who need them, like Owlet’s BabySat model (which is also FDA-cleared).

This stamp of approval from the FDA means the Owlet Dream Sock was “clinically tested in both home and hospital environments, and proven to be as accurate as medical-grade baby monitoring technology and compliant with all relevant performance and safety standards by independent laboratories,” according to the brand.

While most people are used to hearing something is “FDA-approved,” being FDA-cleared is the terminology used for approved medical devices. The De Novo phrasing just means this is the first device of its kind to be cleared.

These are the two new screens coming soon to your Owlet app, Baby’s Live Health Readings and Health Notifications.Owlet

How that the Dream Sock’s new features have rolled out, what should parents expect? You will now be able to see your baby’s pulse rate and oxygen saturation levels in the Baby’s Live Health Readings portion of the app. The Owlet app will also provide notifications using lights and an alarm if your child’s readings fall outside the normal ranges. The Dream Sock is only cleared for use on babies between 1 and 18 months old, and 6 to 30 pounds.

If you already own the Owlet, fear not: you do not have to buy a new one in order to have the “FDA-cleared” version. All the hardware stays the same. You’ll receive a prompt to update your app and once it’s done, you’re good to go. Customers who buy an Owlet new will have access to the FDA-cleared features automatically, according to a representative for Owlet.

If you’re considering purchasing an Owlet Dream Sock and wondering about the Owlet BabySat, that’s the brand’s prescription-only device for babies with acute or chronic medical conditions. It’s designed to be used with a doctor’s guidance, and some insurances may cover it because it’s a medical device. If you’re a parent who just wants to keep a close eye on your otherwise healthy baby, the Dream Sock is the monitor for you.

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