FDA 510(k)

Wearable Ambulatory Blood Pressure Monitor (WBP-02A)

K-Number: K251581 · 2026-02-13

ApplicantShenzhen Hingmed Medical Instrument Co., Ltd.

Decision Date2026-02-13

Product CodeDXN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Wearable Ambulatory Blood Pressure Monitor (WBP-02A) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Hingmed Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2026-02-13 under 510(k) number K251581. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wearable Ambulatory Blood Pressure Monitor (WBP-02A)?

Wearable Ambulatory Blood Pressure Monitor (WBP-02A) is a medical device that received FDA 510(k) clearance on 2026-02-13. The listed applicant is Shenzhen Hingmed Medical Instrument Co., Ltd.. The 510(k) number is K251581.

When did Wearable Ambulatory Blood Pressure Monitor (WBP-02A) receive FDA 510(k) clearance?

Wearable Ambulatory Blood Pressure Monitor (WBP-02A) received FDA 510(k) clearance on 2026-02-13, under 510(k) number K251581.

Who is the listed applicant for Wearable Ambulatory Blood Pressure Monitor (WBP-02A)?

The FDA 510(k) record lists Shenzhen Hingmed Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wearable Ambulatory Blood Pressure Monitor (WBP-02A)?

The FDA product code for Wearable Ambulatory Blood Pressure Monitor (WBP-02A) is DXN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07240831Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring (ABPM)RECRUITING NCT07694570Feasibility Study: Continuous ECG and Blood Pressure Monitoring With the M2VS Sensor SystemNOT_YET_RECRUITING NCT06699056AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable MonitorRECRUITING NCT05524909Full-scale Intervention Study: Genetic Risk Communication and WearablesCOMPLETED NCT06610448Wearable Evaluation of Ambulatory Readings for Blood PressureRECRUITING NCT06905613Technical Feasibility Study of a Novel Wearable Capnograph (MARIE) in an Emergency Care Environment, Part 1COMPLETED

Other records listing Shenzhen Hingmed Medical Instrument Co., Ltd. as applicant

K251307Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)K231984Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP)

Related Devices (Code: DXN)

K261061BP Go (BPP-855)Wellvii, Inc.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.K261136Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)Guangzhou Daxin Health Technology Co., Ltd.K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)Microlife Corporation K253126Wrist Blood Pressure Monitor (XW-05)Shenzhen Ziqing Medical Equipment Co., Ltd.K260693VicorderCS (VCS-SYS-1100)80 Beats Medical GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.