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.

Clearance details

Applicant: Guangzhou Daxin Health Technology Co., Ltd.
Product code: 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 ↗

Recent devices under product code DXN

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K261082 — Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)2026-07-23
K253126 — Wrist Blood Pressure Monitor (XW-05)2026-06-18
K260693 — VicorderCS (VCS-SYS-1100)2026-06-16
K253059 — Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)2026-06-15
K253124 — Upper arm electronic blood pressure monitor (XB-01)2026-06-03

More clearances from Guangzhou Daxin Health Technology Co., Ltd.

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K243082 — Infrared Thermometer2025-04-25

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.