Wrist Type Automatic Blood Pressure Monitor

FDA 510(k) K172972 · Shenzhen Jiacom Technology CO ., Ltd.

Substantially Equivalent

510(k) numberK172972

Submission

Device name
Wrist Type Automatic Blood Pressure Monitor
Applicant
Shenzhen Jiacom Technology CO ., Ltd.
Shenzhen, CN
Received
September 26, 2017
Decision date
March 2, 2018
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

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K261929Upper Arm Blood pressure monitor (BP7155D)DXN · Special OMRON Healthcare, Inc.09/10/2026SE
K254000Happy Health Blood Pressure MonitorDXN · Traditional Happy Health, Inc.09/03/2026SE
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

More from 80 Beats Medical GmbH

510(k)DeviceDecision
K172874Infrared ThermometerFLL · Traditional 07/12/2018SE
K172894Infrared ThermometerFLL · Traditional 05/17/2018SE
K172896Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A…DXN · Traditional 01/26/2018SE

Questions and answers

When was Wrist Type Automatic Blood Pressure Monitor cleared by the FDA?

Wrist Type Automatic Blood Pressure Monitor (K172972) received a 510(k) decision of Substantially Equivalent on March 2, 2018, 157 days after the submission was received.

What is the product code of K172972?

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