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FDA 510(k)

Wearable Ambulatory Blood Pressure Monitor (WBP-02A)

K-Number: K251581 · 2026-02-13

ApplicantShenzhen Hingmed Medical Instrument Co., Ltd.
Decision Date2026-02-13
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Wearable Ambulatory Blood Pressure Monitor (WBP-02A) is a medical device manufactured by Shenzhen Hingmed Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2026-02-13 under approval number K251581. 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 Wearable Ambulatory Blood Pressure Monitor (WBP-02A)?

Wearable Ambulatory Blood Pressure Monitor (WBP-02A) is a medical device that received FDA 510(k) clearance on 2026-02-13. It is manufactured by Shenzhen Hingmed Medical Instrument Co., Ltd.. The 510(k) number is K251581.

When was Wearable Ambulatory Blood Pressure Monitor (WBP-02A) approved by the FDA?

Wearable Ambulatory Blood Pressure Monitor (WBP-02A) received FDA 510(k) clearance on 2026-02-13, under approval number K251581.

What company makes Wearable Ambulatory Blood Pressure Monitor (WBP-02A)?

Wearable Ambulatory Blood Pressure Monitor (WBP-02A) is manufactured by Shenzhen Hingmed Medical Instrument Co., Ltd..

What is the FDA product code for Wearable Ambulatory Blood Pressure Monitor (WBP-02A)?

The FDA product code for Wearable Ambulatory Blood Pressure Monitor (WBP-02A) 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 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 NCT07099092 Causal Mechanisms of Odor-Guided Behavior in Humans NOT_YET_RECRUITING

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: 40388896 Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates. Neonatology (2025)

Other Devices by Shenzhen Hingmed Medical Instrument Co., Ltd.

K231984Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP) K251307Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)

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.

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