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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 the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. It received FDA 510(k) clearance on 2026-02-17 under 510(k) 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. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The 510(k) number is K252805.

When did YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) receive FDA 510(k) clearance?

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

Who is the listed applicant for YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)?

The FDA 510(k) record lists Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04796285A Validation Study of the Lab Clasp Device: A Point of Care Sepsis Risk MonitorACTIVE_NOT_RECRUITINGNCT05690633Feasibility of Obtaining Pulse Oximetry Readings From the OropharynxCOMPLETEDNCT05977686Hemoglobin Testing in Pregnant PatientsRECRUITING

Other records listing Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261571Manual Wheelchair (H008, PCK7)K252779YUWELL® Electronic Blood Pressure Monitor (YE630CR)K253228YUWELL® Electronic Blood Pressure Monitor (YE650AR)K242736Portable Oxygen Concentrator (Spirit-3)K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)K213825Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A

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Related Devices (Code: DQA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK253109Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)Shenzhen Best Electronics 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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