Owlet seeks FDA clearance for prescription pediatric monitor

Owlet announced today that it has submitted a 510(k) premarket notification to the FDA for a new prescription monitoring device for infants.

The Lehi, Utah–based company’s device uses pulse oximetry technology. Physicians could prescribe it to assist with in-home monitoring of babies who are patients. Parents receive alerts from the Owlet device when their child’s heart rate or oxygen saturation level (SpO2) does not fall within prescribed ranges.

“As noted in our recent earnings release, this is a major milestone for Owlet as we work toward our mission, representing several years of work, including clinical and safety studies,” CEO and co-founder Kurt Workman said in a news release.

“This device will help the most vulnerable of babies, and we are optimistic about and excited for the opportunity ahead as we develop and expand our core technologies to include medical devices.”

Responding to FDA warning letter
A team of parents founded Owlet in 2012 with the idea that better baby monitoring products could provide parents with more peace of mind. The company has created an ecosystem of baby monitoring products.

However, the company reported in 2021 that it was halting sales of its Smart Sock in the U.S. after receiving an FDA warning letter over its regulatory status.

Owlet said at the time that the warning letter did list safety concerns. Rather, FDA said the Smart Sock needed classification as a medical device in the U.S. because of its heart rate and oxygen notifications. Owlet responded to the warning letter with plans to pursue FDA marketing authorization for the features.

In the company’s Q2 earnings release in August, Workman said Owlet was pivoting to significantly reduce planned operating expenses and seek a short-term goal of breaking even. MassDevice