Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Digital Blood Pressure Monitor

K-Number: K231250 · 2023-11-28

ApplicantGuangdong Genial Technology Co., Ltd.
Decision Date2023-11-28
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Digital Blood Pressure Monitor is a medical device manufactured by Guangdong Genial Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-11-28 under approval number K231250. 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 Digital Blood Pressure Monitor?

Digital Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2023-11-28. It is manufactured by Guangdong Genial Technology Co., Ltd.. The 510(k) number is K231250.

When was Digital Blood Pressure Monitor approved by the FDA?

Digital Blood Pressure Monitor received FDA 510(k) clearance on 2023-11-28, under approval number K231250.

What company makes Digital Blood Pressure Monitor?

Digital Blood Pressure Monitor is manufactured by Guangdong Genial Technology Co., Ltd..

What is the FDA product code for Digital Blood Pressure Monitor?

The FDA product code for Digital Blood Pressure Monitor is DXN.

Related Clinical Trials

NCT07260890 Paired Comparison of SVV and PVI Accuracy COMPLETED NCT07614139 Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders COMPLETED NCT07613762 High-Flow Nasal Cannula on Exercise Tolerance in Heart Failure Patients Undergoing Cardiac Rehabilitation. NOT_YET_RECRUITING NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT06940752 VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters ENROLLING_BY_INVITATION NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 41623865 Case Report: Hypertensive encephalopathy presents with complex types of sleep breathing events. Frontiers in cardiovascular medicine (2025)

Other Devices by Guangdong Genial Technology Co., Ltd.

K231245Digital Blood Pressure Monitor (Arm Type) K231243Finger Clip Pulse Oximeter K240333Wearable Digital Thermometer (T31) K232678Digital Thermometer, Model T28, T28L

Related Devices (Code: DXN)

K162092Evolv Model BP7000 Upper Arm Blood Pressure MonitorOmron Healthcare, Inc. K161708Arm automatic blood pressure monitorShenzhen Pump Medical System Co., Ltd. K162230Fully Automatic Electronic Blood Pressure MonitorAdon Health Co., Ltd. K160349Electronic SphygmomanometerGuangdong Biolight Meditech Co., Ltd. K161846Automatic Arm Bluetooth Blood Pressure MonitorTruly Instrument Limited K161886Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure DeviceGuangdong Transtek Medical Electronics Co., Ltd.

Official Source

View on FDA Database →

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

↑