Home / 510(k) Clearances / K261394

510(k) K261394

Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus) by JOYTECH Healthcare Co., Ltd. — Product Code DXN

K261394 is an FDA 510(k) premarket notification submitted by JOYTECH Healthcare Co., Ltd. for the device "Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)". The FDA issued a decision of Substantially Equivalent on August 26, 2026. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2026
Date Received
April 29, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type

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FDA data resources