Cleared Traditional

YUWELL? Electronic Blood Pressure Monitor (YE650AR)

K253228 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Cardiovascular
Feb 2026
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K253228 is an FDA 510(k) clearance for the YUWELL? Electronic Blood Pressure Monitor (YE650AR), a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. (Danyang, CN). The FDA issued a Cleared decision on February 23, 2026, 147 days after receiving the submission on September 29, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K253228 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2025
Decision Date February 23, 2026
Days to Decision 147 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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