With the clearance, Stork is available for at-home monitoring of oxygen saturation, pulse rate, and skin temperature in babies without a prescription.

RT’s Three Key Takeaways: 

  1. Masimo’s Stork baby monitoring system has received 510(k) clearance from the FDA, making it available to parents or caregivers without a prescription.
  2. Stork is designed for use with healthy babies aged 0-18 months, offering monitoring capabilities to enhance safety and peace of mind for caregivers.
  3. Stork monitors key vitals, including oxygen saturation level, pulse rate, and skin temperature.

Masimo announced the US Food and Drug Administration (FDA) granted 510(k) clearance to Stork, a baby monitoring system that provides alarms to parents or other caregivers for use with healthy babies 0-18 months of age, without the need for a prescription.

The over-the-counter (OTC) version of Stork utilizes the same Masimo pulse oximetry technology that monitors millions of babies in hospitals every year. The FDA-cleared OTC version of Masimo Stork monitors a baby’s key vitals data including oxygen saturation level (SpO2), pulse rate, and skin temperature. Stork notifies caregivers with visual and audible alarms if a baby’s SpO2 or pulse rate readings fall outside of preset ranges.

Stork leverages the same pulse oximetry technology that has been used on babies in the neonatal intensive care unit (NICU) for decades. Known as Signal Extraction Technology, or SET, this technology has helped clinicians reduce the incidence of neonatal blindness from retinopathy of prematurity and has led to improvements in screening newborns for critical congenital heart disease.

Indications for Masimo Stork Monitoring System

Masimo Stork is indicated for spot-checking and continuous monitoring of SpO2 and pulse rateduring no motion, motion, and low perfusion conditions in infants and neonates who are 0 to 18 months of age and between 6 and 30 pounds. Masimo Stork OTC is also indicated for continuous skin temperature measurements of infants and neonates who are 0 to 18 months of age and between 6 and 30 pounds. Masimo Stork is indicated for use in home environments.

Masimo Stork is not intended to replace the monitoring, diagnosis, or treatment provided by a physician or healthcare provider. Masimo Stork is not intended for use with infants and neonates previously diagnosed with cardiovascular or respiratory disease or conditions.

Stork bundles are currently available at major and specialty retailers nationwide and at masimo.com as a non-medical device for general health and wellness purposes. Alongside the FDA clearance, Masimo will make Stork’s new alarm features available to all existing and new Stork users through the Masimo Stork app, in an update scheduled to be released this summer. FDA-cleared OTC Stork bundles will be available for purchase online and at retailers this summer.

Photo caption: Masimo Stork

Photo credit: Business Wire