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FDA 510(k)

YUWELL® Electronic Blood Pressure Monitor (YE650AR)

K-Number: K253228 · 2026-02-23

ApplicantJiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Decision Date2026-02-23
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

YUWELL® Electronic Blood Pressure Monitor (YE650AR) 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 2026-02-23 under 510(k) number K253228. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the YUWELL® Electronic Blood Pressure Monitor (YE650AR)?

YUWELL® Electronic Blood Pressure Monitor (YE650AR) is a medical device that received FDA 510(k) clearance on 2026-02-23. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The 510(k) number is K253228.

When did YUWELL® Electronic Blood Pressure Monitor (YE650AR) receive FDA 510(k) clearance?

YUWELL® Electronic Blood Pressure Monitor (YE650AR) received FDA 510(k) clearance on 2026-02-23, under 510(k) number K253228.

Who is the listed applicant for YUWELL® Electronic Blood Pressure Monitor (YE650AR)?

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® Electronic Blood Pressure Monitor (YE650AR)?

The FDA product code for YUWELL® Electronic Blood Pressure Monitor (YE650AR) is DXN.

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)K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)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: DXN)

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.

K261061BP Go (BPP-855)Wellvii, Inc.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.K261136Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)Guangzhou Daxin Health Technology Co., Ltd.K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)Microlife CorporationK253126Wrist Blood Pressure Monitor (XW-05)Shenzhen Ziqing Medical Equipment Co., Ltd.K260693VicorderCS (VCS-SYS-1100)80 Beats Medical GmbH

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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