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FDA 510(k)

Wrist Blood Pressure Monitor (XW-05)

K-Number: K253126 · 2026-06-18

ApplicantShenzhen Ziqing Medical Equipment Co., Ltd.
Decision Date2026-06-18
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Wrist Blood Pressure Monitor (XW-05) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Ziqing Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K253126. 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 Wrist Blood Pressure Monitor (XW-05)?

Wrist Blood Pressure Monitor (XW-05) is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Shenzhen Ziqing Medical Equipment Co., Ltd.. The 510(k) number is K253126.

When did Wrist Blood Pressure Monitor (XW-05) receive FDA 510(k) clearance?

Wrist Blood Pressure Monitor (XW-05) received FDA 510(k) clearance on 2026-06-18, under 510(k) number K253126.

Who is the listed applicant for Wrist Blood Pressure Monitor (XW-05)?

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

What is the FDA product code for Wrist Blood Pressure Monitor (XW-05)?

The FDA product code for Wrist Blood Pressure Monitor (XW-05) 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.

NCT07633886Multi-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_RECRUITINGNCT07713576Clinical Trial of Wrist Ambulatory Blood Pressure Monitor in Conformance With the ISO 81060-2:2018+AMD1:2020+AMD2:2024.COMPLETED

Other records listing Shenzhen Ziqing Medical Equipment Co., Ltd. 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.

K253124Upper arm electronic blood pressure monitor (XB-01)

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.K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)Microlife CorporationK260693VicorderCS (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

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

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