Pregnancy SmartShop formulas

Is it safe? · Pregnancy Smart

Are baby breathing and oxygen monitors like Owlet worth it?

Assigned clinical reviewerSharyn Harrison· CNM, NPDraft · pending clinical reviewUpdated

What does the evidence say about baby breathing and oxygen monitors?

  1. FDA warns that unauthorized wearable, mattress-sensor, or camera-based infant monitors claiming to track heart rate, oxygen saturation, breathing rate, or temperature may fail to detect real changes in a baby's vital signs, may trigger inaccurate alerts that lead to unnecessary medical visits, and have not been reviewed by the agency for accuracy or safety. 1
  2. FDA states plainly that it is not aware of any clinical or scientific evidence showing that currently available baby products lower a baby's chance of SIDS, and that infant monitors of any kind are not a replacement for adult supervision or a safe sleep setup. 1
  3. In October 2021, FDA sent Owlet Baby Care a warning letter stating that its Smart Sock line met the legal definition of a medical device, because marketing described the sock as tracking a baby's oxygen level and heart rate and sending alerts when those readings left a preset range, and the products were being sold without the marketing clearance that classification legally requires; FDA ordered the company to stop distributing the Smart Sock for those uses. 2
  4. A home cardiorespiratory monitor is not recommended as a way to lower SIDS risk: the landmark CHIME study found that brief drops in heart rate or breathing occur at similar rates in healthy infants and those thought to be at higher risk, and only a small share of infants with documented apnea episodes went on to die of SIDS, which undercuts the idea that catching these events on a monitor meaningfully changes outcomes. 3
  5. Consumer smartphone-linked pulse-ox wearables, the sock and onesie style products this category is built on, are generally sold as wellness gadgets rather than regulated medical devices, and published accuracy studies describe their sensitivity for detecting true drops in oxygen or heart rate as very poor. 3
  6. Owlet's newer Dream Sock later went through FDA's De Novo review pathway and was authorized as an over-the-counter infant pulse rate and oxygen saturation monitor, a distinct regulatory status from the original Smart Sock marketing claims that triggered the 2021 warning letter. 4

Understanding what you're buying

QuestionWhy it matters
Is this specific product FDA-authorized, and for what claim?Search the exact device name in FDA's device databases; authorization and claims vary by product, even within the same brand
Is it marketed as a medical device or a wellness product?Wellness products are not reviewed by FDA for accuracy the way a cleared medical device is
Does the marketing mention SIDS specifically?FDA says it knows of no evidence any current baby product lowers SIDS chance; be skeptical of marketing that implies otherwise
Does my baby have a specific medical indication for monitoring?If so, this is a conversation with your pediatric team about a clinically appropriate device, not a general consumer purchase

Frequently asked questions

Do monitors like Owlet actually lower my baby's chance of SIDS?

There's no evidence they do. The FDA says it is not aware of any clinical or scientific evidence that a currently available baby product lowers a baby's chance of SIDS, and both FDA and AAP-aligned research describe home monitors, wearable or otherwise, as unproven for that specific purpose.

Is the Owlet Smart Sock an FDA-cleared medical device?

The original Smart Sock line was marketed with health-tracking claims before it had the FDA clearance that classification requires, which led to a 2021 FDA warning letter. Owlet's newer Dream Sock later went through FDA's official review process and holds a different regulatory status; check a specific product's current authorization rather than assuming based on the brand name alone.

How accurate are consumer pulse oximetry baby monitors?

Published research on this device category describes sensitivity for catching genuine drops in oxygen or heart rate as very poor, and these products are typically sold as wellness gadgets rather than regulated diagnostic equipment. A reassuring reading on the app is not the same as a validated medical measurement.

Can I use one of these monitors instead of following safe sleep guidance?

No. FDA explicitly states these devices are not a replacement for adult supervision or a safe sleep environment. A firm, flat, empty sleep surface and back sleeping remain the core protective steps regardless of what any monitor shows.

What's the difference between the Smart Sock and the Dream Sock?

The Smart Sock is the earlier product line named in FDA's 2021 warning letter over unauthorized health-tracking claims. The Dream Sock is a newer product that went through FDA's De Novo pathway and was authorized as an over-the-counter infant pulse rate and oxygen saturation monitor, a different and more current regulatory footing than the original claims that drew scrutiny.

When would a doctor actually prescribe a home monitor for my baby?

Clinical home cardiorespiratory monitoring is generally reserved for specific situations, such as a prior severe apparent life-threatening event, a technology-dependent infant, or certain preterm infants being followed after a documented event, not as routine reassurance equipment for a healthy baby. That decision and the specific device belong to your pediatric team, not a general product purchase.

What should I check before buying one of these products?

Look up the specific device by name in FDA's public device databases to see whether it has been authorized and for what claim, since products in this category range from wellness gadgets with no clearance to devices that have completed FDA review for a defined use. Don't assume two products in the same category carry the same regulatory status.

Are false alarms a real problem with these devices?

Yes. FDA specifically warns that inaccurate readings from unauthorized infant monitors can trigger alerts that lead to unnecessary medical evaluation, on top of the separate risk of a device failing to catch a real change. Both directions of error are part of why these products are not managed as a substitute for clinical judgment.

Related in the library

References

  1. Do Not Use Unauthorized Infant Devices for Monitoring Vital Signs: FDA Safety Communication

    FDA · https://www.fda.gov/medical-devices/safety-communications/do-not-use-unauthorized-infant-devices-monitoring-vital-signs-fda-safety-communication

  2. Owlet Baby Care, Inc. MARCS-CMS 616354 : October 05, 2021

    FDA · https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/owlet-baby-care-inc-616354-10052021

  4. FDA De Novo classification order for Dream Sock (DEN220091)

    FDA · https://www.accessdata.fda.gov/cdrh_docs/pdf22/DEN220091.pdf

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.