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FDA 510(k)

Accurate 24 Non-invasive blood pressure monitor

K-Number: K222658 · 2023-06-21

ApplicantAccurate Meditech, Inc.
Decision Date2023-06-21
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Accurate 24 Non-invasive blood pressure monitor is a medical device manufactured by Accurate Meditech, Inc.. It received FDA 510(k) clearance on 2023-06-21 under approval number K222658. 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 Accurate 24 Non-invasive blood pressure monitor?

Accurate 24 Non-invasive blood pressure monitor is a medical device that received FDA 510(k) clearance on 2023-06-21. It is manufactured by Accurate Meditech, Inc.. The 510(k) number is K222658.

When was Accurate 24 Non-invasive blood pressure monitor approved by the FDA?

Accurate 24 Non-invasive blood pressure monitor received FDA 510(k) clearance on 2023-06-21, under approval number K222658.

What company makes Accurate 24 Non-invasive blood pressure monitor?

Accurate 24 Non-invasive blood pressure monitor is manufactured by Accurate Meditech, Inc..

What is the FDA product code for Accurate 24 Non-invasive blood pressure monitor?

The FDA product code for Accurate 24 Non-invasive 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 NCT06940752 VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters ENROLLING_BY_INVITATION NCT07614100 Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves NOT_YET_RECRUITING 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 Accurate Meditech, Inc.

K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)

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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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