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FDA 510(k)

KOROT Blood Pressure Monitor (KOROT P3 Accurate)

K-Number: K250091 · 2025-03-14

ApplicantKorot Co., Ltd.
Decision Date2025-03-14
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KOROT Blood Pressure Monitor (KOROT P3 Accurate) is a medical device manufactured by Korot Co., Ltd.. It received FDA 510(k) clearance on 2025-03-14 under approval number K250091. 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 KOROT Blood Pressure Monitor (KOROT P3 Accurate)?

KOROT Blood Pressure Monitor (KOROT P3 Accurate) is a medical device that received FDA 510(k) clearance on 2025-03-14. It is manufactured by Korot Co., Ltd.. The 510(k) number is K250091.

When was KOROT Blood Pressure Monitor (KOROT P3 Accurate) approved by the FDA?

KOROT Blood Pressure Monitor (KOROT P3 Accurate) received FDA 510(k) clearance on 2025-03-14, under approval number K250091.

What company makes KOROT Blood Pressure Monitor (KOROT P3 Accurate)?

KOROT Blood Pressure Monitor (KOROT P3 Accurate) is manufactured by Korot Co., Ltd..

What is the FDA product code for KOROT Blood Pressure Monitor (KOROT P3 Accurate)?

The FDA product code for KOROT Blood Pressure Monitor (KOROT P3 Accurate) 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: 41623865 Case Report: Hypertensive encephalopathy presents with complex types of sleep breathing events. Frontiers in cardiovascular medicine (2025)

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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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