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FDA 510(k)

Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)

K-Number: K261082 · 2026-07-23

ApplicantMicrolife Corporation
Decision Date2026-07-23
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) is the device name listed in this FDA 510(k) record. The listed applicant is Microlife Corporation. It received FDA 510(k) clearance on 2026-07-23 under 510(k) number K261082. 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 Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)?

Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) is a medical device that received FDA 510(k) clearance on 2026-07-23. The listed applicant is Microlife Corporation. The 510(k) number is K261082.

When did Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) receive FDA 510(k) clearance?

Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) received FDA 510(k) clearance on 2026-07-23, under 510(k) number K261082.

Who is the listed applicant for Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)?

The FDA 510(k) record lists Microlife Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)?

The FDA product code for Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) 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.

NCT07713576Clinical Trial of Wrist Ambulatory Blood Pressure Monitor in Conformance With the ISO 81060-2:2018+AMD1:2020+AMD2:2024.COMPLETEDNCT06969560WeRoaM: Wearable Remote Monitoring in Heart FailureRECRUITINGNCT07633886Multi-Centre Based Evaluation of the Performance and Safety of the Corsano CardioWatch 287-2 Blood Pressure Monitoring Device at Wrist Against BP-Cuff Measurements (COR-BP)NOT_YET_RECRUITING

Other records listing Microlife Corporation as applicant

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.

K253180Microlife Digital Peak Flow Meter, Model PF200B (PF200B)K251120Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B)

Related Devices (Code: DXN)

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.

K261136Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)Guangzhou Daxin Health Technology Co., Ltd.K253126Wrist Blood Pressure Monitor (XW-05)Shenzhen Ziqing Medical Equipment Co., Ltd.K260693VicorderCS (VCS-SYS-1100)80 Beats Medical GmbHK253059Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)Tournicare Pty, Ltd.K253124Upper arm electronic blood pressure monitor (XB-01)Shenzhen Ziqing Medical Equipment Co., Ltd.K253570Blood Pressure Monitor (W06LT)Shenzhen Jamr Technology Co., Ltd.

Official Source

View on FDA Database →

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

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