FDA Product Code QYU: Infant Pulse Rate And Oxygen Saturation Monitor For Over-the-counter Use
An Infant Pulse Rate And Oxygen Saturation Monitor For Over-the-counter Use Is A Device That Uses Photoplethysmography To Measure Pulse Rate And Oxygen Saturation In Infants. The Device May Contain Alarms That Alert The Caregiver When Vital Sign(s) Go Outside Preset Threshold(s).
Leading manufacturers include Masimo Corporation.
FDA 510(k) Cleared Infant Pulse Rate And Oxygen Saturation Monitor For Over-the-counter Use Devices (Product Code QYU)
About Product Code QYU - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QYU since 2023, with 1 receiving FDA clearance (average review time: 232 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
QYU devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →