KOROT Blood Pressure Monitor (KOROT P3 Accurate)

The KOROT P3 Accurate is a digital blood pressure monitor that measures systolic and diastolic blood pressure and pulse rate in adult patients with upper arm circumference between 22–52 cm. It uses non-invasive measurement via an inflatable cuff and employs both oscillometric and automated auscultation methods to detect blood pressure.

Compared to the predicate device (K221764), the KOROT P3 Accurate expands the arm circumference range from the predicate's range to 22–52 cm, adds Bluetooth connectivity (for data transmission only, not active monitoring), includes GUI changes, adds new functions, incorporates component changes, improves pulse accuracy, enhances data storage, and modifies transport/storage conditions.

ISO 81060-2 is cited as the standard used for clinical validation of the device's blood pressure measurement claims across the full arm circumference range of 22–52 cm.

The device is substantially equivalent because it retains the same intended use (measuring blood pressure and pulse rate in adults), uses identical measurement technologies (oscillometric and auscultation methods), and is based on a legally marketed predicate device. All modifications were verified with rationales, and additional clinical and non-clinical testing (including bench testing per the same standards as the predicate) supports that the expanded arm circumference range and other enhancements do not affect safety or effectiveness.