Happy Health Blood Pressure Monitor

FDA 510(k) K254000 · Happy Health, Inc.

Substantially Equivalent

510(k) numberK254000

Submission

Device name
Happy Health Blood Pressure Monitor
Applicant
Happy Health, Inc.
Austin, TX, US
Received
December 15, 2025
Decision date
September 3, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DXN – System, Measurement, Blood-Pressure, Non-Invasive
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1130
Specialty
Cardiovascular

Other 510(k)s with product code DXN

510(k)DeviceApplicantDecision
K261929Upper Arm Blood pressure monitor (BP7155D)DXN · Special OMRON Healthcare, Inc.09/10/2026SE
K262658Automatic Digital Blood Pressure monitor (LD-526)DXN · Special Honsun (Nantong) Co., Ltd.08/31/2026SE
K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus…DXN · Traditional JOYTECH Healthcare Co., Ltd.08/26/2026SE
K261061BP Go (BPP-855)DXN · Traditional Wellvii, Inc.08/13/2026SE
K253425Arm-type Fully Automatic Digital Blood Pressure Monitor…DXN · Traditional Joytech Healthcare Co. , Ltd.08/13/2026SE
K261136Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)DXN · Traditional Guangzhou Daxin Health Technology Co., Ltd.07/23/2026SE
K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)DXN · Traditional Microlife Corporation07/23/2026SE
K253126Wrist Blood Pressure Monitor (XW-05)DXN · Traditional Shenzhen Ziqing Medical Equipment Co., Ltd.06/18/2026SE
K260693VicorderCS (VCS-SYS-1100)DXN · Traditional 80 Beats Medical GmbH06/16/2026SE
K253059Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)DXN · Traditional Tournicare Pty, Ltd.06/15/2026SE

More from Tournicare Pty, Ltd.

510(k)DeviceDecision
K242224Happy Health Home Sleep TestMNR · Traditional 06/18/2025SE
K240236Happy Ring Health Monitoring SystemMWI · Traditional 09/24/2024SE

Questions and answers

When was Happy Health Blood Pressure Monitor cleared by the FDA?

Happy Health Blood Pressure Monitor (K254000) received a 510(k) decision of Substantially Equivalent on September 3, 2026, 262 days after the submission was received.

What is the product code of K254000?

The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.