Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · Class II · Cleared Mar 5, 2026
| K-number | K252779 |
| Device name | YUWELL® Electronic Blood Pressure Monitor (YE630CR) |
| Applicant | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. |
| Product code | DXN |
| Device class | Class II |
| Decision date | Mar 5, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.1130 |
The YUWELL® Electronic Blood Pressure Monitor (Model YE630CR) is a rechargeable lithium battery-powered, automatic, noninvasive upper-arm blood pressure measurement device intended for over-the-counter use in patients over 12 years old with arm circumference 22–45 cm. It measures systolic and diastolic blood pressure plus pulse rate using the oscillometric method and can be used at home or in healthcare facilities.
The device uses oscillometric measurement with automatic electric pump inflation and rapid deflation, similar to the predicate. Key differences include: rechargeable lithium battery (vs. AAA batteries), broader arm circumference range (22–45 cm vs. 22–42 cm), slightly higher cuff pressure range (0–300 mmHg vs. 0–299 mmHg), optional time/date setting, optional voice broadcast, optional dual-unit display (mmHg or kPa), and 3-minute auto-shutoff (vs. 2-minute). Both achieve ±3 mmHg accuracy and ±5% pulse rate accuracy.
ISO 81060-2:2018+AMD1:2020 (blood pressure accuracy); IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-11 (electrical safety and EMC); IEC 80601-2-30 (specific performance standard); ISO 10993 (biocompatibility); IEC 62133-2 (lithium battery); IEC 62366-1 (usability). Clinical testing included 93 subjects for blood pressure validation and 35 subjects for pulse rate validation per ISO 81060-2 criteria.
The subject device is substantially equivalent to the predicate (Omron Evolv BP7000) because both use identical oscillometric measurement principles, achieve identical accuracy specifications (±3 mmHg for pressure, ±5% for pulse rate), and comply with the same recognized consensus standards. Differences in battery type, arm circumference range, and optional features (time/date, voice, dual units) do not present additional safety or effectiveness risks because they are independent of the blood pressure algorithm. Clinical testing demonstrated the device meets ISO 81060-2 criteria for both blood pressure and pulse rate accuracy.
View the full FDA submission: accessdata.fda.gov