Cleared Traditional

Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)

K251307 · Shenzhen Hingmed Medical Instrument Co., Ltd. · Cardiovascular
Jan 2026
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K251307 is an FDA 510(k) clearance for the Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i), 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 January 12, 2026, 259 days after receiving the submission on April 28, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K251307 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 2025
Decision Date January 12, 2026
Days to Decision 259 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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