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FDA 510(k)

Upper arm electronic blood pressure monitor (XB-01)

K-Number: K253124 · 2026-06-03

ApplicantShenzhen Ziqing Medical Equipment Co., Ltd.
Decision Date2026-06-03
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Upper arm electronic blood pressure monitor (XB-01) 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 2026-06-03 under 510(k) number K253124. 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 Upper arm electronic blood pressure monitor (XB-01)?

Upper arm electronic blood pressure monitor (XB-01) is a medical device that received FDA 510(k) clearance on 2026-06-03. The listed applicant is Shenzhen Ziqing Medical Equipment Co., Ltd.. The 510(k) number is K253124.

When did Upper arm electronic blood pressure monitor (XB-01) receive FDA 510(k) clearance?

Upper arm electronic blood pressure monitor (XB-01) received FDA 510(k) clearance on 2026-06-03, under 510(k) number K253124.

Who is the listed applicant for Upper arm electronic blood pressure monitor (XB-01)?

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 Upper arm electronic blood pressure monitor (XB-01)?

The FDA product code for Upper arm electronic blood pressure monitor (XB-01) 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)RECRUITINGNCT07523269WEARABLE-BP: Wearable Everyday Automated Readings to Enable Assessment of Blood Pressure ControlRECRUITINGNCT07694570Feasibility Study: Continuous ECG and Blood Pressure Monitoring With the M2VS Sensor SystemNOT_YET_RECRUITINGNCT07696910Perioperative Hypoglycemia in Diabetic Patients Undergoing Vitrectomy: a Masked CGM Prospective Observational StudyNOT_YET_RECRUITINGNCT07631910Application of Multimodal Intervention in the Prevention of Postoperative Nausea and Vomiting After Gynecological Laparoscopic SurgeryNOT_YET_RECRUITING

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.

K253126Wrist Blood Pressure Monitor (XW-05)

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 CorporationK253126Wrist 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.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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