Wrist Blood Pressure Monitor (XY-W01A, XY-W01B)

The Wrist Blood Pressure Monitor (models XY-W01A and XY-W01B) is a noninvasive oscillometric blood pressure measurement device intended for adults with wrist circumferences of 13.5–21.5 cm. It measures systolic and diastolic blood pressure and pulse rate using an automatic electric pump and deflation valve, with results displayed on an LCD screen. The device is powered by two AAA batteries and can store up to 90 measurement sets in memory.

The subject device uses a piezoelectric resistance sensor for pressure measurement with ±3 mmHg accuracy and ±5% accuracy for pulse rate (40–180 beats/min). It operates in temperature ranges of +10°C to +40°C and humidity of 15–85% RH. Minor dimensional differences exist compared to the predicate (73×65×88 mm vs. 61×24.1×87 mm) and the device weighs approximately 150 g without batteries. The pulse rate range is narrower than the predicate but meets IEC 80601-2-30 requirements.

The device complies with IEC 60601-1:2005+A1:2012+A2:2020 (general safety), IEC 60601-1-11:2015 (home healthcare environment), IEC 80601-2-30:2018 (automated sphygmomanometer requirements), IEC 60601-1-2:2014+A1:2020 (electromagnetic compatibility), ISO 10993-10:2010 and ISO 10993-5:2009 (biological evaluation), and FDA software validation guidance. Clinical testing followed ISO 81060-2:2018 with 120 subjects (ages 12–85 years).

The subject device is substantially equivalent to predicate K231310 because both share identical product code (DXN), regulation (21 CFR 870.1130), classification (Class II), indications for use, measurement method (cuff oscillometric), wrist circumference range (13.5–21.5 cm), accuracy specifications, and over-the-counter status. Minor differences in dimensions, weight, operating conditions, and pulse rate range do not affect safety or effectiveness, as confirmed by nonclinical testing demonstrating compliance with applicable standards and clinical testing showing mean error of ±5 mmHg or less with no adverse events.