Korotkoff sound blood pressure monitor

The Korotkoff Sound Blood Pressure Monitor is a digital, non-invasive device that automatically measures systolic and diastolic blood pressure and pulse rate in adults and adolescents using an upper-arm cuff. It can detect irregular heart rhythms (AFib, tachycardia) and evaluate blood pressure variability and time-in-target-range metrics. The device is intended for use in medical facilities and at home.

The subject device extends the cuff size range by 2 cm (upper limit only) to cover larger adult arm sizes already addressed by predicate devices. It features additional software-based informational alerts (AFib, blood pressure variability, time-in-target-range) that do not modify core measurement or diagnosis. The device has different power supply/IP rating and slightly different operating environments, but all differences are secondary features not affecting the primary blood pressure measurement function.

ISO 13485 (Quality Management System), ISO 10993-1 (Biocompatibility), IEC 60601-1:2005 and amendments (Medical electrical equipment safety), IEC 60601-1-2 (EMC), IEC 80601-2-30 (Non-invasive sphygmomanometers), IEC 80601-1-11:2015 (Home healthcare environment), IEC 60601-1-6 (Usability), and ISO 81060-2 (Blood pressure measurement accuracy).

The subject device and predicate share the same primary intended use, target population, and well-established non-invasive upper-arm BP measurement technology with comparable accuracy and safety. All differences are secondary features (extended cuff range, informational alerts, different power ratings, application in home vs. clinical settings). Performance is validated over the full measurement range per applicable standards. Clinical data from 90-person trials demonstrated equivalent safety and effectiveness profiles to the predicate device.