Clearance Summary
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) received FDA 510(k) clearance under submission number K261394, sponsored by JOYTECH Healthcare Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2026-08-26.
- Submission: K261394
- Applicant / Sponsor: JOYTECH Healthcare Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2026-08-26
Classification & Regulation
This clearance is catalogued under FDA product code DXN and 21 CFR 870.1130, within the Cardiovascular review panel as a Class II device.