FDA forces Utah-based company Owlet to pull baby monitor sock off the market

SALT LAKE CITY — Utah-based company Owlet just took a big hit from the U.S. Food and Drug Administration.

The company sells the wildly-popular Smart Sock — a device that is wrapped around the baby’s foot, like a sock, to track the baby’s heart rate, oxygen level and sleep trends.

The company has sold over 1 million of the monitors in the last six years. But now, the FDA says the company is breaking federal guidelines and can no longer sell the product based on regulatory status and its use as a “medical device.” Owlet has a disclaimer on its website for its U.S. version of the sock, discussing the letter and warning from the FDA.

Owlet released the following statement to KSL-TV on Tuesday:

“Owlet received a Warning Letter from the FDA regarding the Smart Sock’s regulatory status in the United States. The letter we received from the agency did not identify any safety concerns about the Smart Sock; rather, the FDA asserts that the Smart Sock should be classified as a medical device in the U.S. because of the heart rate and oxygen notifications. Based on the FDA’s recent letter, Owlet plans to pursue marketing authorization from the FDA for these features.

“As a result of the letter and in light of our plans to submit a device application to the FDA, we will no longer be selling the Smart Sock. We plan to offer a new sleep monitoring solution, which we believe will be available soon. We also plan to continue to support our current customers. We will notify customers of any updates to the Smart Sock products that have already been distributed. This action is specific to the U.S. only and no other countries or regions are affected by this.

“After six years on the market, with four versions launched and over 1 million babies monitored, we are extremely proud of the innovation and technology Owlet has delivered. We will continue to stay focused on our mission and are cooperating with the FDA so we can continue to provide sleep monitoring products and solutions to parents and babies.”

Parents like Katie Mayne agree there should be regulations. But she doesn’t see FDA approval as a green light. Instead, she said she has never expected the monitor to diagnose or cure a condition or disease. Mayne’s youngest two children were both born five weeks premature. She said the Owlet Smart Sock gave her, and her husband, significant peace of mind.

“She was five weeks early,” says Katie about her now 1-year-old daughter, Claire. “ When they’re premature they have some breathing problems, their lungs aren’t all the way developed.”

That’s why she made sure she had the Owlet Smart Sock when she brought her baby home. She loved how easy it was to put on her baby’s foot, but more importantly, she loved how it worked.

“Just to make sure, in addition to the precautions we were already taking, that we could catch anything that might be going on.”

Luckily for the Maynes, Claire is now a healthy 1-year-old and never had any issues.

On the company’s website this week, Owlet said the app for the Owlet Smart Sock will not be impacted for those who have already downloaded it. For new customers, a new app, along with a new product, will be coming soon.