Ningbo Ranor Medical Technology Co., Ltd. · Class II · Cleared Jan 9, 2026
| K-number | K253142 |
| Device name | Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D) |
| Applicant | Ningbo Ranor Medical Technology Co., Ltd. |
| Product code | DXN |
| Device class | Class II |
| Decision date | Jan 9, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.1130 |
The Arm Blood Pressure Monitor (models MJ1D, MJ1DS, MJ3D, MJ5D, MJ6D, MJ8D, RN3D, MJ4D, RN1D, RN2D) is an automatic, non-invasive blood pressure monitor for home use that measures systolic and diastolic blood pressure and pulse rate in adults. It uses an inflatable cuff wrapped around the upper arm, includes memory for 60 measurement sets per two users, and features optional voice broadcast functionality. The device is powered by four AAA dry batteries and automatically shuts down after one minute of inactivity.
The subject device matches the predicate in design method (oscillometric), measurement items (systolic, diastolic, pulse), arm circumference (22–32 cm), patient contact materials (nylon TPU cuff per ISO-10993), and inflation/deflation methods (automatic electronic pump and pressure release valve). Minor differences include max cuff pressure of 294 mmHg versus 300 mmHg, pulse rate range of 40–190 beats/min versus 40–180 beats/min, and the addition of segment LED display option in one model (MJ1DS).
The device complies with IEC 60601-1:2020 (general electrical safety), IEC 60601-1-2:2020 (electromagnetic compatibility), IEC 60601-1-11:2020 (home healthcare environment), IEC 80601-2-30:2018 (automated non-invasive sphygmomanometers), and ISO 10993-1 (biocompatibility). Blood pressure accuracy is ±3 mmHg and pulse accuracy is ±5% of reading value.
Substantial equivalence is established because the subject device uses identical software version, algorithm, measurement logic, and core functionality as the cleared predicate device (RN-032A, RN-032C, K193456), with no code changes or new functions introduced. All 10 models share the same software design, cuff type, measurement range, principle, key components, and circuit diagrams. Biocompatibility testing from K193456 remains valid, and no additional clinical testing is required since monitoring technology, sensors, algorithms, and measurement accuracy are unchanged from the predicate.
View the full FDA submission: accessdata.fda.gov