Guangdong Xinyu Electronic and Technology Co., Ltd. · Class II · Cleared Feb 3, 2025
| K-number | K241590 |
| Device name | Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09) |
| Applicant | Guangdong Xinyu Electronic and Technology Co., Ltd. |
| Product code | DXN |
| Device class | Class II |
| Decision date | Feb 3, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.1130 |
The Arm Blood Pressure Monitor (models XY-B01 through XY-B09) is an automated, noninvasive blood pressure measurement device intended for use by medical professionals or at home. It measures systolic and diastolic blood pressure and pulse rate in adults using the oscillometric method with an arm cuff, automatically inflating and deflating to complete each measurement.
The device uses a semiconductor pressure sensor and oscillometric measurement method on the upper arm for adults with arm circumference of 22-32 cm. It features automatic inflation via piezoelectric pump and automatic rapid deflation. Some models are powered by 4×AA batteries (XY-B02) or 4×AAA batteries (other models), with measurement ranges of 0-295 mmHg for pressure and 40-180 beats/min for pulse rate. It includes an LCD display and memory function storing 2×60 measurement sets.
The device complies with IEC 60601-1:2005+A1:2012+A2:2020, IEC 60601-1-11:2015, IEC 80601-2-30:2018, IEC 60601-1-2:2014+A1:2020, ISO 10993-10:2010, and ISO 10993-5:2009. Clinical testing followed ISO 81060-2:2018 requirements. FDA software validation guidance from January 11, 2002, and July 20, 2023 device software content guidance were applied.
The subject device is substantially equivalent to predicate K222926 because both share identical intended use, environment of use, patient population, contraindications, and operating principles (oscillometric cuff measurement on upper arm). Both use semiconductor pressure sensors with ±3 mmHg accuracy and ±5% pulse rate accuracy, automatic piezoelectric inflation/deflation, and LCD displays. Minor differences in measurement range, power source, and operating conditions do not affect safety or effectiveness; testing validates the subject device meets the same performance standards (IEC 80601-2-30) as the predicate. Clinical testing of 120 subjects demonstrated mean errors within ISO 81060-2:2018 limits (±5 mmHg systolic/diastolic with ≤8 mmHg standard deviation).
View the full FDA submission: accessdata.fda.gov