Updated November 2026
Talk to your pediatrician first
Talk to your child's pediatrician before you buy or use any monitor. Alerts from a wearable are not a substitute for supervision. FDA says no device has been authorized to prevent SIDS. For safe-sleep basics, read the American Academy of Pediatrics safe sleep guidance.
This guide is general information, not medical advice. We only list wearable monitors that FDA has authorized for infants or children, because FDA has warned parents about the rest. If your child has trouble breathing, turns blue or gray, or you think it is an emergency, call 911 (US) or 112 (EU) right away. Do not wait for a device alert.
What FDA Says About Infant Monitors
- FDA recommends that parents not use unauthorized infant monitors that claim to measure vital signs such as pulse rate or oxygen saturation, because their safety and effectiveness have not been reviewed and they may give inaccurate measurements. (FDA safety communication, September 16, 2025)
- FDA-authorized infant monitoring devices have product code QYU. You can search FDA's De Novo and 510(k) databases by device name to check.
- FDA says it is not aware of evidence that currently available baby products prevent or reduce the chance of SIDS, and that no device has been authorized to prevent SIDS or SUID.
FDA-Authorized Wearable for Infants
| Device | FDA authorization | Intended use (from the FDA record) | Limits |
|---|---|---|---|
| Owlet Dream Sock (also included in the Dream Duo bundle) | De Novo DEN220091, product code QYU, granted November 8, 2023 | Over-the-counter use at home for infants 1 to 18 months old and 6 to 30 lbs. It provides notifications that prompt the caregiver to assess the infant, and displays pulse rate and oxygen saturation trends. | Not intended to replace traditional methods of monitoring, diagnosis or treatment. Not intended for infants previously diagnosed with cardiovascular or respiratory disease or conditions. It does not notify for every episode of a low reading. |
Fit by age: the authorization covers infants 1 to 18 months and 6 to 30 lbs only. If your child is older, younger or outside that weight range, ask your pediatrician which FDA-authorized option, if any, is appropriate.
Alert Features and Their Limits
Alerts can prompt you to check on your child, but FDA describes them as a supplement to your own decision to seek medical care, not a replacement for supervision. Alerts can be missed, can be delayed and can be wrong, and they do not tell you why a reading changed. Do not rely on an alert instead of checking on your child.
Adult Smart Rings Are Not Cleared for Children
Rings with an FDA 510(k) for SpO2, such as the Wellue O2Ring (K242876) and RingConn (K260490), are cleared for adults only. They are not cleared for children. See our guide to FDA-cleared smart rings with SpO2 for the adult details.
How to Evaluate Any Monitor
- Check the FDA databases for the exact device name and look for product code QYU or an indication that names children or infants.
- Read the intended use, age range and weight range, and compare them with your child.
- Ignore any product that claims to prevent SIDS or to keep your child safe.
- Ask your pediatrician before you buy.
Where Healify Fits
Healify's AI health coach is a general wellness coach. It is not a medical device, it does not diagnose, treat, monitor or prevent any disease, and it cannot interpret your child's readings. For questions about your child's breathing or oxygen levels, talk to your pediatrician.
FAQs
Can a wearable oxygen monitor prevent SIDS?
No. FDA says it is not aware of any clinical or scientific evidence that currently available baby products prevent or reduce the chance of SIDS, and that no devices, including infant monitors, have been authorized to prevent SIDS or SUID.
How do I check whether an infant monitor is FDA-authorized?
Search FDA's De Novo and 510(k) databases using the device name. According to FDA, authorized infant monitoring devices have product code QYU.
Should I talk to a pediatrician before buying a monitor?
Yes. Talk to your pediatrician before buying or using any monitor. FDA also advises that if medical care depends on accurate monitoring, you should talk to your health care provider about an appropriate FDA-authorized device for your child's needs.
Are adult smart rings cleared for children?
No. The Wellue O2Ring (K242876) and RingConn (K260490) are cleared for adults only and are not cleared for children.