Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856)

The Automatic Upper Arm Blood Pressure Monitor is a noninvasive device designed to measure systolic, diastolic blood pressure, and pulse rate in adults using an inflatable cuff wrapped around the upper arm. It employs the oscillometric method with an electronic capacitive pressure sensor. The device is intended for use by medical professionals or at home, includes Bluetooth connectivity to transmit data to a mobile app, and comes in 18 models in two types (arm type and tunnel type) with multiple cuff sizes.

The subject device measures pressure up to 294 mmHg (slightly higher than the predicate's 280 mmHg) with ±3 mmHg accuracy. It operates at 10–90% relative humidity (less restrictive than predicate's 15–90%). Power sources include 4 AA batteries or DC 6V adapters (arm type 1A; tunnel type 1.5A), whereas the predicate uses only batteries. The device includes new Bluetooth connectivity and mobile app integration. Cuff sizes are identical to the predicate, and the measuring method, resolution, and patient population remain the same.

IEC 60601-1:2020 (electrical safety), IEC 60601-1-2:2020 (electromagnetic compatibility), IEC 60601-1-11:2020 (home healthcare environment), ISO 80601-2-30:2018 (blood pressure monitors), ISO 81060-1:2007, ISO 81060-2 (clinical validation), and ISO 10993 series (biocompatibility).

The subject device uses identical principles, software, algorithms, and sensors as the predicate device K193627 for blood pressure measurement. The materials (cuff and cuff cover) are identical in formulation, processing, and cleaning to previously cleared predicates. The minor differences in pressure range (294 vs. 280 mmHg) and operating humidity (10–90% vs. 15–90%) are supported by test data demonstrating the device maintains safety and performance within these parameters. The addition of Bluetooth and app connectivity does not alter the core measurement function. Since the clinical performance can be represented by the predicate device's data (which was tested to ISO 81060-2), and all safety and performance characteristics are equivalent or non-inferior, substantial equivalence is established.