FDA 510(k)

YUWELL® Electronic Blood Pressure Monitor (YE630CR)

K-Number: K252779 · 2026-03-05

ApplicantJiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Decision Date2026-03-05

Product CodeDXN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

YUWELL® Electronic Blood Pressure Monitor (YE630CR) is a medical device manufactured by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. It received FDA 510(k) clearance on 2026-03-05 under approval number K252779. 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 (YE630CR)?

YUWELL® Electronic Blood Pressure Monitor (YE630CR) is a medical device that received FDA 510(k) clearance on 2026-03-05. It is manufactured by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The 510(k) number is K252779.

When was YUWELL® Electronic Blood Pressure Monitor (YE630CR) approved by the FDA?

YUWELL® Electronic Blood Pressure Monitor (YE630CR) received FDA 510(k) clearance on 2026-03-05, under approval number K252779.

What company makes YUWELL® Electronic Blood Pressure Monitor (YE630CR)?

YUWELL® Electronic Blood Pressure Monitor (YE630CR) is manufactured by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd..

What is the FDA product code for YUWELL® Electronic Blood Pressure Monitor (YE630CR)?

The FDA product code for YUWELL® Electronic Blood Pressure Monitor (YE630CR) is DXN.

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Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 41623865 Case Report: Hypertensive encephalopathy presents with complex types of sleep breathing events. Frontiers in cardiovascular medicine (2025)

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: DXN)

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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.