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)

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

K-Number: K242352 · 2025-02-05

ApplicantAccurate Meditech, Inc.
Decision Date2025-02-05
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Accurate Mini Non-invasive blood pressure monitor (AMB-001) is a medical device manufactured by Accurate Meditech, Inc.. It received FDA 510(k) clearance on 2025-02-05 under approval number K242352. 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 Mini Non-invasive blood pressure monitor (AMB-001)?

Accurate Mini Non-invasive blood pressure monitor (AMB-001) is a medical device that received FDA 510(k) clearance on 2025-02-05. It is manufactured by Accurate Meditech, Inc.. The 510(k) number is K242352.

When was Accurate Mini Non-invasive blood pressure monitor (AMB-001) approved by the FDA?

Accurate Mini Non-invasive blood pressure monitor (AMB-001) received FDA 510(k) clearance on 2025-02-05, under approval number K242352.

What company makes Accurate Mini Non-invasive blood pressure monitor (AMB-001)?

Accurate Mini Non-invasive blood pressure monitor (AMB-001) is manufactured by Accurate Meditech, Inc..

What is the FDA product code for Accurate Mini Non-invasive blood pressure monitor (AMB-001)?

The FDA product code for Accurate Mini Non-invasive blood pressure monitor (AMB-001) 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: 40388896 Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates. Neonatology (2025)

Other Devices by Accurate Meditech, Inc.

K222658Accurate 24 Non-invasive blood pressure monitor

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.

↑