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FDA 510(k)

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

K-Number: K252805 · 2026-02-17

ApplicantJiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Decision Date2026-02-17
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) is a medical device manufactured by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. It received FDA 510(k) clearance on 2026-02-17 under approval number K252805. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)?

YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) is a medical device that received FDA 510(k) clearance on 2026-02-17. It is manufactured by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The 510(k) number is K252805.

When was YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) approved by the FDA?

YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) received FDA 510(k) clearance on 2026-02-17, under approval number K252805.

What company makes YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)?

YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) is manufactured by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd..

What is the FDA product code for YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)?

The FDA product code for YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) is DQA.

Related Clinical Trials

NCT07260890 Paired Comparison of SVV and PVI Accuracy COMPLETED NCT04121923 Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea COMPLETED NCT07226193 Detecting Peripheral Artery Disease With the Pulse RECRUITING NCT05914324 Outpatient Pediatric Pulse Oximeters in Africa ACTIVE_NOT_RECRUITING NCT05690633 Feasibility of Obtaining Pulse Oximetry Readings From the Oropharynx COMPLETED NCT07527000 SpO2 Validation Study - All.Health Algo Oximeter Software COMPLETED

Other Devices by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

K170605Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D K201864YUWELL Infrared Thermometer K200939Electronic Blood Pressure Monitor K203583YUWELL infrared ear thermometer: YHT101, YHT200 K221372YUWELL Electronic Blood Pressure Monitor K212385YUWELL Finger Pulse Oximeter

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Related Devices (Code: DQA)

K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation K160231Model X-100C CO-Met™ Oximetry SystemNonin Medical, Inc. K160940Masimo Disposable Transflectance Forehead SensorMasimo Corporation K153021Fingertip Pulse Oximeter A310Amemo, Inc. K160268Fingertip Pulse Oximeter MD300CG11/MD300CG51Beijing Choice Electronic Technology Co., Ltd. K161560Fingertip Pulse Oximeter MD300CN310Beijing Choice Electronic Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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