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# FDA Clears At-home Pulse Baby Monitor
- URL: https://www.fdaweb.com/fda-clears-at-home-pulse-baby-monitor/
- Published: 2023-06-22T12:00:00.000Z
- Updated: 2026-09-14T18:40:23.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154748

FDA has cleared an Owlet 510(k) for its [BabySat](https://www.owletcare.com/babysat-fda-clearance?ref=fdaweb.com), an at-home pulse-oximetry device for monitoring babies. The device, which features the company’s wire-free sock design, provides a real-time display of a baby’s pulse rate and oxygen saturation level (SpO2) and alerts parents when these readings fall outside of prescribed ranges, Owlet says.