FDA 510(k) clearance · back to tracker

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)

JOYTECH Healthcare Co., Ltd. cleared K261394 on 2026-08-26, decision: substantially equivalent

K-number

K261394

Sponsor

JOYTECH Healthcare Co., Ltd.

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)

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-08-26

Product code

DXN

Advisory committee

Cardiovascular

Medical specialty

Cardiovascular

Regulation number

870.1130

Official FDA record

Open K261394on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.