Yes, Owlet now has FDA clearance for two of its products, but the path to that clearance was rocky. The Owlet Dream Sock received FDA De Novo classification as a Class II medical device on November 8, 2023. A separate prescription-only product, the BabySat, also holds FDA clearance. The original Smart Sock, however, was pulled from shelves in 2021 after the FDA issued a warning letter declaring it was being sold illegally without authorization.
The Dream Sock’s FDA Clearance
The Dream Sock is the consumer version of Owlet’s infant monitoring sock. It tracks your baby’s blood oxygen level and pulse rate, sending real-time notifications to the Owlet Dream App on your phone when readings fall outside normal ranges. You’ll get alerts for low oxygen, low pulse rate, and high pulse rate.
The FDA classified the Dream Sock as a Class II device, the same regulatory category that includes powered wheelchairs and pregnancy tests. To earn that classification, Owlet submitted clinical data through the De Novo pathway, which is the route companies use when no similar legally marketed device already exists. The FDA created a new regulatory category for the Dream Sock, meaning future competitors will need to meet the same standards.
The Dream Sock is designed for healthy babies between 1 and 18 months old, weighing between 6 and 30 pounds. It’s available directly to consumers without a prescription.
How Accurate Is It?
The FDA clearance was based on several clinical studies. In controlled testing where infants experienced drops in oxygen levels, the Dream Sock measured oxygen saturation with a root mean square error of 2.51% without motion and 2.46% during simulated motion. Both figures fell within the FDA’s acceptance threshold of less than 3%. Pulse rate accuracy was similarly strong, with errors of about 2.5 beats per minute against an acceptance threshold of 5 bpm.
In a home-use study, accuracy held up well in real-world conditions, with average errors of 2.16% for oxygen saturation and 3.53 bpm for pulse rate. A separate study conducted in a neonatal intensive care unit found the device correctly identified normal oxygen levels 99.86% of the time and normal heart rates 100% of the time. These numbers suggest the sock reliably distinguishes between normal readings and genuinely concerning drops.
The BabySat: Owlet’s Prescription Product
Owlet also sells the BabySat, a prescription-only pulse oximeter cleared through the FDA’s traditional 510(k) process. It serves a different purpose than the Dream Sock. While the Dream Sock sends the same preset notifications to every parent, the BabySat allows a healthcare provider to set custom alarm thresholds tailored to a specific baby’s medical needs. This makes it suited for infants with known health concerns who need closer monitoring at home.
The BabySat covers the same age and weight range as the Dream Sock (1 to 18 months, 6 to 30 pounds) and is intended for both spot-checking and continuous monitoring. Your pediatrician or specialist would need to prescribe it and configure the settings.
Why the Original Smart Sock Was Pulled
Understanding the current products requires knowing what happened with the original. In October 2021, the FDA sent Owlet a warning letter stating that the company was marketing the Smart Sock without the required clearance or approval. The core issue: the Smart Sock measured blood oxygen and pulse rate and alerted parents when readings were abnormal. The FDA determined that those functions made it a medical device by definition, because it was intended to diagnose conditions like oxygen desaturation and abnormally slow heart rate.
Owlet had been selling the Smart Sock as a consumer wellness product, sidestepping the regulatory process. The FDA’s letter declared the product “adulterated” under federal law because Owlet had no premarket approval, no De Novo classification, and no investigational device exemption. Owlet voluntarily stopped selling the Smart Sock shortly after.
The Dream Sock that returned to market in late 2023 does essentially what the original Smart Sock did, but now with the FDA clearance the agency demanded. The difference isn’t so much in the technology as in the regulatory status behind it: Owlet went through formal clinical testing, submitted the data, and received legitimate authorization.
What FDA Clearance Does and Doesn’t Mean
FDA clearance confirms that the Dream Sock performs as advertised, accurately measuring oxygen levels and pulse rate within established margins of error. It does not mean the device prevents sudden infant death syndrome (SIDS) or any other medical emergency. The American Academy of Pediatrics notes that no baby monitor has been shown to reduce the risk of SIDS, and monitoring technology should never substitute for direct supervision and safe sleep practices like placing babies on their backs in an empty crib.
The practical value of the Dream Sock is that it gives you data about your baby’s vital signs in real time and alerts you to readings that fall outside normal ranges. For many parents, that information provides peace of mind. But the clearance is specifically for measurement accuracy, not for the device’s ability to prevent harm. If your baby has a diagnosed medical condition that requires customized monitoring thresholds, the prescription BabySat is the more appropriate option.