Cleared Traditional

Wearable Ambulatory Blood Pressure Monitor (WBP-02A)

K251581 · Shenzhen Hingmed Medical Instrument Co., Ltd. · Cardiovascular
Feb 2026
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K251581 is an FDA 510(k) clearance for the Wearable Ambulatory Blood Pressure Monitor (WBP-02A), a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Shenzhen Hingmed Medical Instrument Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on February 13, 2026, 266 days after receiving the submission on May 23, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K251581 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 2025
Decision Date February 13, 2026
Days to Decision 266 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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