BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)

The BP1000 is a portable, fingertip-based blood pressure monitor for home use that measures systolic and diastolic pressure in adults aged 22–59 without arrhythmias, peripheral artery disease, or pregnancy. It uses optical sensors, pressure sensors, and a mobile app to display results and is intended for spot-check measurements only, not continuous monitoring or clinical decision-making.

The BP1000 differs from the predicate (Accurate 24) in three ways: measurement location (fingertip versus wrist), pressure application method (linear finger pressure versus wrist clamp), and detection principle (oscillometric algorithm versus Bramwell-Hill/Moens-Korteweg equations). Both devices use optical photoplethysmogram (PPG) and contact pressure to estimate blood pressure via arterial biomechanics principles.

IEC 60601-1:2020, IEC 60601-1-11:2020, IEC 60601-1-2:2020, IEC 62471:2006, ISO 13485:2016, ISO 14971:2019, ISO 10993-1:2018, IEC 62366-1:2020, ISO 81060-2:2018 (with AMD1:2020), IEC TS 60601-4-2:2024, and USEMCSC C63.27-2021.

The BP1000 is substantially equivalent because it has the same intended use as the predicate—a digital monitor for spot-check blood pressure measurements in adults for home use—and both employ similar physiological signals (PPG and pressure) based on established arterial biomechanics. Although measurement location, pressure application, and algorithmic approach differ, clinical testing per ISO 81060-2 demonstrated equivalent accuracy, and the differences do not introduce new safety or effectiveness risks.