Owlet stopped selling its Smart Sock—here’s what parents need to know

Owlet has stopped selling its lineup of Smart Socks after the Food and Drug Administration sent the company a warning letter about the way they market its products.

The Smart Sock is a popular product for new parents, as it monitors your baby’s vital signs like oxygen levels and heart rate. The device then transmits the information—including warnings if data moves into “unsafe” levels—to the corresponding app on the parent’s phone.

Why is the Owlet Smart Sock discontinued?

In the letter, the FDA states that the Smart Sock should be classified as a medical device. The FDA did not cite any safety concerns with the product itself—just with the way the device has been marketed.

In a statement, Owlet said that they are pausing sales of the socks pending FDA approval. The company also says it plans to offer a new sleep monitoring solution in the near future.

“Owlet received a Warning Letter from the FDA regarding the Smart Sock’s regulatory status in the United States,” the statement reads. “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.”

A change.org petition fighting to keep Smart Socks on the market currently has over 112,000 signatures from parents who use the device.

Can I still use my Smart Sock?

If you currently own or use a Smart Sock, Owlet says it’s still safe to use. The product has not been recalled. The FDA is just requesting that Owlet complies with the agency’s regulations for proper authorization as a medical device.

What experts say about the Smart Sock

The Owlet Smart Sock has been on the market since 2015. In 2017, physicians from the Journal of the American Medical Association (JAMA) stated that digitally connected infant monitors like the Owlet Smart Sock, while innovative and showing potential to improve care, are not necessary for monitoring healthy infants at home. They also feel strongly that devices like these should be subject to regulation testing by the FDA to assure safety and efficacy.

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