Microlife Corporation · Class II · Cleared Aug 6, 2025
| K-number | K251120 |
| Device name | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) |
| Applicant | Microlife Corporation |
| Product code | DXN |
| Device class | Class II |
| Decision date | Aug 6, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.1130 |
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) is a fully automatic device that measures systolic and diastolic blood pressure and pulse rate in adults using a non-invasive oscillometric technique with an inflatable cuff around the upper arm (circumference 22–40 cm). The device detects irregular heartbeats and can transmit measurement data via Bluetooth to a smartphone running the Microlife Connected Health+ mobile app.
The subject device uses the same oscillometric measurement method and fundamental algorithm as the predicate (BP3KV1-5K) to determine blood pressure and pulse rate. Key differences include: smaller physical dimensions (145 × 67 × 28 mm vs. 157.5 × 105 × 61.5 mm); removal of PC link/Blood Pressure Analyzer software function; removal of MyBP averaging function; power source limited to AAA batteries only (no AC/DC adapter); addition of touch pad technology for user interface; and a tube-free cuff sized 22–40 cm (vs. predicate's 22–52 cm with tube).
IEC 60601-1, IEC 60601-1-2:2014, IEC 60601-1-11:2020, AAMI/ANSI/ES60601-1, AAMI/ANSI/IEC 80601-2-30:2018, ISO 14971:2019, ISO 81060-2, AAMI/ANSI/ISO 10993-1, 10993-5, and 10993-10. Non-clinical testing covered electrical safety, electromagnetic compatibility, and mechanical performance; clinical validation tested blood pressure measurement accuracy.
The subject device shares the identical oscillometric measurement algorithm, mechanism of operation, and blood pressure measurement technology with the predicate. All differences (physical dimension, cuff type/size, power source, and non-clinical software features like PC link and MyBP) do not affect measurement accuracy, safety, or essential performance; these changes were validated by testing per IEC 80601-2-30 and ISO 81060-2. The new tube-free cuff design was clinically validated and confirmed to perform equivalently. Therefore, the device is substantially equivalent because the core measurement function and safety/effectiveness profile remain identical.
View the full FDA submission: accessdata.fda.gov