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

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K252805 ↗

FDA Product Code

DQA

Device Class

Class II

Regulation

21 CFR Part 870.2700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Electronic blood pressure monitor

  Class IIa

  CE/MDR

• oxygen concentrator

  Class IIb

  CE/MDR

• YUWELL® Finger Pulse Oximeter

  Class IIa

  CE/MDR

• Probe cover

  Class IIa

  CE/MDR

• Nebulizing Mesh

  Class I

  CE/MDR

• Infrared ear thermometer

  Class IIa

  CE/MDR

See all devices from Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. →

• Are these oximeters designed for single-use or reusable clinical environments, and how should they be handled if reused?

  The Yuwell Finger Pulse Oximeters (YX105, YX106, YX110, YX310) are intended for both single-use and reusable clinical settings, depending on the specific model variant. If reused, they must adhere to strict sterility standards to ensure patient safety, as outlined in the manufacturer’s instructions. Proper cleaning, disinfection, and maintenance protocols are critical to prevent contamination and preserve functionality.

• What types of clinical monitoring is this device primarily authorized for, and how does it function?

  This device is authorized for cardiovascular monitoring, specifically to measure arterial oxygen saturation (SpO₂) and pulse rate in real-time. It works by transmitting light through a finger to detect hemoglobin oxygenation levels, allowing clinicians to track blood oxygenation and heart rate non-invasively. It’s particularly useful in settings where continuous or intermittent cardiovascular assessment is required.

• How should these oximeters be stored to ensure they remain accurate and functional?

  The Yuwell Finger Pulse Oximeters must be stored according to the manufacturer’s instructions to maintain accuracy and functionality. While specific storage conditions (e.g., temperature, humidity) aren’t detailed in the provided data, proper handling—such as avoiding exposure to extreme environments, moisture, or physical damage—is essential. Follow the included guidelines to prevent calibration drift or operational failures.

• What regulatory pathway was followed for FDA clearance, and what does this mean for buyers?

  The device underwent a traditional 510(k) review through the FDA’s Cardiovascular (CV) advisory committee, with a decision code of SESE (Substantially Equivalent). This means the manufacturer demonstrated that the Yuwell oximeters are substantially equivalent to a legally marketed predicate device in terms of technology and performance. For buyers, this indicates the device meets FDA safety and effectiveness standards for its intended use in cardiovascular monitoring.

• Are there different models, and if so, how do they differ in terms of clinical use?

  The Yuwell Finger Pulse Oximeter is available in four models (YX105, YX106, YX110, YX310), though the provided data does not specify functional or performance differences between them. The key distinction lies in their intended use context: some may be optimized for single-use (e.g., disposable sensors), while others support reusable applications in clinical settings. Check the manufacturer’s documentation for model-specific guidelines on usage, sterility, and maintenance.