LOCAL NEWS

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

Nov 24, 2021, 8:42 AM

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.

KSL 5 TV Live

Top Stories

Local News

Emergency lights...
Eliza Pace

Man arrested in hit-and-run that killed 11-year-old boy

West Valley City Police Department announced an arrest of a man in the hit-and-run that left an 11-year-old boy dead.
10 hours ago
Save Money - First Time Homebuyer...
Tamara Vaifanua

Experts advise teens how to prepare economically in this time of uncertainty

One expert says inflation will most likely impact the class of 2023 as they look to either continue their education or find a job.
10 hours ago
FILE: Back-to-school shopping (Photo by Justin Sullivan/Getty Images)...
Matt Gephardt & Sloan Schrage

Gephardt Busts Inflation: Saving money on back-to-school supplies even with higher prices

With inflation running amok this year, parents are tackling big price hikes on top of the stress. Fortunately, there are ways they can still save money.
10 hours ago
...
Lauren Steinbrecher

Good Samaritan tries to chase hit-and-run suspect in West Valley City who killed 11-year old boy

A witness is recounting trying to follow a hit-and-run driver, after the driver killed an 11-year old boy in West Valley City and took off.
10 hours ago
Salt Lake Police released body camera footage of an incident with Salt Lake Police and Megan Joyce ...
Cary Schwanitz

Death of woman in Salt Lake police custody ruled a homicide, under investigation

The death of a woman restrained by four Salt Lake police officers in January is under investigation by the department’s officer involved critical incident protocol.
1 day ago
(KSL TV)...
Ladd Egan

Economists: Wage growth remains strong but can’t match inflation

The good news is that the upward pressure on wages is expected to continue for a while, the bad news is that the pay increases aren’t enough to match inflation, according to economists with Wells Fargo.
1 day ago

Sponsored Articles

tips how to quit smoking...

7 Tips How to Quit Smoking | Quitting Smoking Might be One of the Hardest Things You Ever Do but Here’s Where You Can Start

Quitting smoking cigarettes can be incredibly difficult. Here are 7 tips how to quit smoking to help you on your quitting journey.
Photo: Storyblocks...
Blue Stakes of Utah 811

Blue Stakes of Utah 811: 5 Reasons To Call 811 Before You Dig When Working in Your Yard

Call before you dig. Even at home, you could end up with serious injuries or broken utilities just because you didn't call Blue Stakes of Utah 811.
Days of...
Days of '47 Rodeo

TRIVIA: How well do you know your rodeo? Take this quiz before you go to the Days of ’47!

The Utah Days of ’47 Rodeo presented by Zions Bank is a one-of-a-kind Gold Medal Rodeo being held July 20-23, 25 at 7:30 PM. The Days of ’47 Rodeo How well do you know your rodeo trivia? Take the quiz to test your know-all before heading out to the Days of ’47 Rodeo at the […]
cyber security through multi factor authentication setup...
Les Olson IT

How multi factor authentication setup helps companies stay safe

Multi factor authentication (MFA) setup is an important security measure that every company should implement for their workers. It’s also wise to install it for your personal and home accounts.
...
Lighting Design

Check out these stunning lamps with stained glass shades

Lamps with stained glass shades are statement pieces that are more than simply aesthetic. They also meet a functional requirement: to light up a room.
Address Bar of internet browser shows internet access...
AARP Utah

Utah voters 50+ support increased access to Internet

The AARP surveyed Utah voters aged 50 plus about internet access and if they support the expansion of broadband, especially in rural areas currently lacking it.
FDA forces Utah-based company Owlet to pull baby monitor sock off the market