Cleared Traditional

YUWELL? Electronic Blood Pressure Monitor (YE630CR)

K252779 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Cardiovascular
Mar 2026
Decision
184d
Days
Class 2
Risk

About This 510(k) Submission

K252779 is an FDA 510(k) clearance for the YUWELL? Electronic Blood Pressure Monitor (YE630CR), a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. (Zhenjiang, CN). The FDA issued a Cleared decision on March 5, 2026, 184 days after receiving the submission on September 2, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K252779 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 2025
Decision Date March 05, 2026
Days to Decision 184 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXN — System, Measurement, Blood-pressure, Non-invasive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1130

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