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Made byOwlet

Dream Sock

Over-the-counter smart sock for infants that reports pulse rate and oxygen level to a phone app, granted by the FDA under the De Novo route.

owletcare.com

At a glance

Type
Device
Platforms
Wearable · iOS · Android
Who it’s for
Caregivers and patients
Where it’s available
United States
Sources cited
2
In the library since
24 September 2026
Regulatory status
FDA De Novo DEN220091, Dream Sock, granted 8 November 2023, product code QYU; sold over the counter.As recorded from the regulator or the company, with its attribution.
Pricing
$299.99 regular price (company product page, read 22 September 2026)

What it does

Dream Sock is worn on an infant's foot and sends readings to the Owlet app on a parent's phone. The company's product page describes it as an FDA-cleared smart baby monitor and a medical-grade pulse oximeter sold over the counter, and lists device support for iOS 14 and later and Android 7 and later.

Independent evidence

Established from a source other than the company.

The FDA granted the De Novo DEN220091, Dream Sock, to Owlet Baby Care on 8 November 2023, product code QYU.

What the company says

The company’s own statements, attributed to it and not presented as established fact.

The company calls it the first and only FDA-cleared baby monitor on the market and says it is clinically validated across all skin tones. The price recorded is the regular price on the company's product page when it was read on 22 September 2026.

More from Owlet

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BabySat

Prescription pulse oximeter worn as a sock, for infants who could benefit from additional monitoring at home under a physician's supervision.

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