Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)

The Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6186, DBP-6286B) are non-invasive devices that automatically measure systolic and diastolic blood pressure and pulse rate in adults and adolescents over 12 years old with arm circumferences of 22-42 cm and 40-56 cm. They use the oscillometric method with an integral piezoelectric pump to inflate the cuff and an automatic deflation valve, analyzing waveform data via microprocessor algorithms. The DBP-6286B includes Bluetooth connectivity to transfer readings to a mobile app for data storage and display.

Compared to the predicate DBP-6286B (K212115), the subject devices add two cuff sizes (22-42 cm and 40-56 cm versus 22-36 cm), increased battery voltage from 3V to 6V (four AAA batteries instead of three), updated Bluetooth module from version 5.0 to 5.2 with shielding, repositioned USB adapter jack from right side to top, added control buttons, and modified external air pump dimensions and voltage while maintaining the same internal structure. The core measurement principle, sensor type, solenoid valve, algorithm, and pressure range remain identical.

IEC 60601-1:2005+AMD1:2012+AMD2:2020 (electrical safety), IEC 60601-1-11:2015+AMD1:2020 (home healthcare), IEC 60601-1-2:2014+AMD1:2020 (EMC), IEC 80601-2-30:2018 (automated non-invasive sphygmomanometers), ISO 81060-2:2018+AMD2020 (clinical investigation), ISO 10993 series (biocompatibility), and FCC Part 15 Subpart C (RF emissions). Clinical validation involved 91 subjects for the 22-42 cm cuff and 85 subjects for the 40-56 cm cuff using mercury sphygmomanometer reference.

The subject devices maintain identical intended use, oscillometric measurement principle, measurement type (inflation-based), core algorithm, pressure sensor technology, and functional performance as the predicate. Differences are minor and non-fundamental: expanded cuff size range is supported by clinical trial data demonstrating accuracy within ISO 81060-2 acceptable limits; higher battery voltage was validated through electrical safety and EMC testing; Bluetooth module upgrade with shielding passed FCC and coexistence testing; and pump modifications passed electrical safety standards without altering measurement capability. None of these changes affect the fundamental technology, safety profile, or clinical effectiveness of blood pressure measurement.