On September 16, 2025, the FDA issued an official safety communication cautioning families against the use of unauthorized infant monitors that claim to measure vital signs, including heart or pulse rate, oxygen saturation, breathing or respiratory rate, and body temperature. 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 Owlet’s top priority. We’re proud to offer parents 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 and giving our partners confidence in the products they carry. 

The FDA emphasized that unauthorized infant devices:

- Have not been reviewed for safety or effectiveness

- Require FDA marketing authorization to be lawfully marketed in the United States

- Do not qualify as general wellness products because they are intended for medical purposes

According to the FDA, the Agency became aware of unauthorized products through routine monitoring of the medical device market and is now taking steps to address the unlawful marketing of these devices.

Owlet: Your Trusted Partner for Peace of Mind

Parents 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.

In 2023, Owlet secured two FDA clearances:

- Dream Sock® – the first FDA-cleared, over-the-counter infant monitoring device and the only one available on the market today (view classification here)

- BabySat® – FDA-cleared for medical use and available through prescription (view classification here)

Learn More

For more details, you can view the FDA’s safety communication here and the Owlet Dream Sock De Novo classification here.