Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D)— 510(k) K253142

Substantially Equivalent

Ningbo Ranor Medical Technology Co., Ltd.

FDA 510(k) clearance K253142 for Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D), Substantially Equivalent on 2026-01-09. Applicant: Ningbo Ranor Medical Technology Co., Ltd..

Clearance details

Applicant: Ningbo Ranor Medical Technology Co., Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2025-09-25
Decision date: 2026-01-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Ningbo, CN

Download summary PDF View on FDA.gov ↗

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.