Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)— 510(k) K261136

Name: FDA 510(k) clearance K261136
Creator: U.S. Food and Drug Administration
Published: 2026-07-23

Substantially Equivalent

Guangzhou Daxin Health Technology Co., Ltd.

FDA 510(k) clearance K261136 for Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D), Substantially Equivalent on 2026-07-23. Applicant: Guangzhou Daxin Health Technology Co., Ltd.. Device class: 2.

Summary

Guangzhou Daxin Health Technology's Blood Pressure Monitor covers six models: M501, M501A, M502, M502A, M502C, and M502D. They're filed under DXN, non-invasive blood pressure measurement systems, and the record doesn't say how they differ.

Class II, 21 CFR 870.1130. Cardiovascular is both the classification panel and the review panel. It came in as a Traditional 510(k).

Guangzhou Daxin filed from Guangzhou, China. Review took 107 calendar days (April 7 to July 23, 2026).

Clearance details

Applicant: Guangzhou Daxin Health Technology Co., Ltd.
Product code: Product code DXN
Device class: Class 2
Regulation: 21 CFR 870.1130
Advisory panel: Cardiovascular
Date received: 2026-04-07
Decision date: 2026-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.