Cleared Traditional

Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)

K250548 · Joytech Healthcare Co. , Ltd. · Cardiovascular
Jun 2025
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K250548 is an FDA 510(k) clearance for the Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186), a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Joytech Healthcare Co. , Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on June 26, 2025, 121 days after receiving the submission on February 25, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K250548 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 2025
Decision Date June 26, 2025
Days to Decision 121 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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