Owlet’s mission is to empower parents with the right information at the right time, to give them more peace of mind, and to help them find more joy in the journey of parenting. This article reviews the functionality of the various Owlet Socks and includes a comparison table for the Notification (Alarm) types. To jump to a specific section, please click one of the links below.
- Dream Sock®
- FDA-cleared Dream Sock® + Health Notifications
- FDA-cleared BabySat®
- Smart Sock 3
- Notifications (Alarms) by Sock Type
Dream Sock® (USA/Canada)
In early 2022, Owlet launched its Dream Sock® smart baby monitor, which replaced Smart Sock® 3 in the US and Canadian markets. This was both an advancement in our sleep technology experience and a response to the FDA. Dream Sock® was launched as a wellness device, eventually showing a live pulse rate and a 10-minute average oxygen saturation. Dream Sock® delivered sleep assist prompts based on variability from the baby’s personal baseline of pulse rate, oxygen saturation, and movement. Dream Sock® introduced sleep features, such as tracking, predictive sleep, and educational content to support healthy sleep development. Dream Sock® is a wellness device, it is not a medical product and should not be used to treat or diagnose medical conditions.
In the US and Canada, Owlet Smart Sock 3 users can convert their device to Dream Sock® and are encouraged to do so if they have an Apple mobile device that is not set to automatic application updates. Near the end of 2023, Owlet received FDA clearance for Dream Sock®+Health Notifications, this clearance prompted Owlet to release live oxygen saturation readings within the Dream App for users within the United States (Canadian users continue to have a 10-minute oxygen saturation average). This change did not include changes to the prompts within the Dream app, users should still expect lavender prompts to behave the same as before. For additional details on your Oxygen experience in Dream App, please visit the Dream Sock Oxygen Readings article.
Owlet encourages all Dream Sock® users located in the US to upgrade to the new FDA-cleared Dream Sock®+Health Notifications experience if their baby is aged 1-18 months and weighing between 6-30 pounds.
FDA-cleared Dream Sock®+ Health Notifications
On November 8th, 2023, Dream Sock® + Health Notifications was granted a De Novo clearance by the FDA as the first ever over-the-counter smart baby monitor medical device. Launched in January 2024, Owlet has introduced parents to their smartest monitor yet. Combining both the health features of Owlet Smart Sock and the sleep features of Dream Sock®, FDA-cleared Dream Sock® + Health Notifications empowers parents with the right information at the right time, supporting their parenting journey. Intended for healthy babies between ages 1-18 months and weighing between 6-30 pounds to assist caregivers in tracking their child’s well-being by monitoring sleep patterns, quality, and duration of sleep.
When enabled (in-home use on healthy infants only), the Owlet Dream Sock® displays pulse rate (PR) and oxygen saturation (SpO2) values and provides a notification in the rare instance that the values move outside of a preset zone (see table below). The alarm limits consider the range of conditions possible across the intended user range and appropriateness has been validated through clinical studies which evaluated the prevalence of clinically actionable alarms. For more details, please visit our website or reference our FAQ article.
FDA-cleared BabySat®
In 2023, Owlet received FDA clearance for the first-ever prescription smart home monitoring device designed with babies in mind. BabySat pulse oximeter is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse rate. It is indicated for spot-checking and/or continuous monitoring of well-perfused patients greater than one-month-old up to 18 months old and weighing between 6 and 30 pounds, in the home environment. BabySat is intended for infants diagnosed with a condition that would benefit from home monitoring under the direction of their infant’s healthcare provider. BabySat is designed to alarm based on pulse rate and oxygen saturation limits set by the infant’s healthcare provider (see table below).
What if I have an Owlet Smart Sock 3?
Owlet Smart Sock 3 provides live pulse rate and oxygen saturation readings and red alerts based on preset ranges (see table below). In late 2021, the FDA asserted that Owlet Smart Sock 3 should be classified as a medical device in the U.S. because of the live pulse rate and oxygen readings as well as the notifications. In response to the FDA, Apple deemed the Owlet Care App to be a medical device app, no longer allowing the Care app to new users in the Apple App Store.
Notifications (Alarms) by Sock Type