Yes. Blueberry’s medical devices are FDA-cleared for their intended use. This includes the oral thermometer and pulse oximeter included in your Blueberry kit, as well as the forehead thermometer, which is available as an optional add-on.
Our otoscope does not require FDA clearance because it functions as a camera rather than a diagnostic device. The otoscope is used to capture images of the ear that can be shared with a Blueberry pediatrician for review. The device itself does not analyze, interpret, or evaluate medical data.
If you'd like additional information about any of the devices included in your Blueberry kit, including regulatory or manufacturer information, please reach out to our Customer Support team at help@blueberrypediatrics.com.