YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)

The YUWELL® Finger Pulse Oximeter (models YX105, YX106, YX110, YX310) is a non-invasive, reusable device that measures functional oxygen saturation (SpO₂) and pulse rate via a finger probe. It is indicated for spot-checking use in adults and children weighing over 30 kg in professional and home settings, and is unsuitable for continuous monitoring, use during motion, or in patients with low perfusion.

The subject device matches the predicate in core specifications including SpO₂ display range (0%–100%), measurement range (70%–100%), accuracy (±2%), pulse rate range (25–250 bpm), and accuracy (±1% or ±1 bpm). Key differences include: two models (YX110, YX310) feature Bluetooth wireless capability (not in predicate but addressed by reference device), wider operating humidity/pressure ranges per IEC 60601-1-11, and OLED displays in some models versus LED-only in the predicate.

ISO 80601-2-61:2017 (Pulse Oximeter Equipment), IEC 60601-1:2015+A1+A2, IEC 60601-1-2:2014 (EMC), IEC 60601-1-11:2015/AMD1:2020 (home healthcare), ISO 10993-1:2018 (biocompatibility), and FDA guidance for software, wireless technology, and cybersecurity in medical devices.

The subject device has identical intended use and substantially similar technological characteristics to the predicate device (K212385). Although differences exist in Bluetooth capability, display types, and operating environments, these do not raise safety or effectiveness concerns because they have been evaluated through design verification and validation testing, and the Bluetooth feature is supported by the reference device. All clinical and non-clinical testing demonstrated equivalent or superior performance, with SpO₂ accuracy within ±2% across the claimed 70%–100% range.