Cleared Traditional

Wrist Blood Pressure Monitor (BPM-W1VL)

K253133 · Shenzhen Imdk Medical Technology Co., Ltd. · Cardiovascular
Feb 2026
Decision
141d
Days
Class 2
Risk

About This 510(k) Submission

K253133 is an FDA 510(k) clearance for the Wrist Blood Pressure Monitor (BPM-W1VL), a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Shenzhen Imdk Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on February 13, 2026, 141 days after receiving the submission on September 25, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K253133 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2025
Decision Date February 13, 2026
Days to Decision 141 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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