Clearance Summary
Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) received FDA 510(k) clearance under submission number K251143, sponsored by Ningbo Ranor Medical Science & Technology Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2025-12-19.
- Submission: K251143
- Applicant / Sponsor: Ningbo Ranor Medical Science & Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2025-12-19
Classification & Regulation
This clearance is catalogued under FDA product code DXN and 21 CFR 870.1130, within the Cardiovascular review panel as a Class II device.