Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L, RN5L)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K251143 ↗

FDA Product Code

DXN

Device Class

Class II

Regulation

21 CFR Part 870.1130

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Arm blood pressure monitor

  Class IIa

  CE/MDR 6078824CE01 Expiring Valid to Dec 2026

• Infrared Thermometer Model Number RN-60A, RN-60B

  Class II

  FDA 510(k) K200471 Active Cleared 19 Jun 2020

• Infrared Thermometer RN-50A, RN-50B

  Class II

  CE/MDR FDA 510(k) K200578 Active Cleared 16 Jul 2020

• blood pressure monitor

  Class IIa

  CE/MDR 6078824CE01 Expiring Valid to Dec 2026 GUDID on market

• Ranor

  Class IIa

  CE/MDR 6078824CE01 Expiring Valid to Dec 2026 GUDID on market

• Arm Blood Pressure Monitor

  Class II

  FDA 510(k) K193456 Active Cleared 16 Jul 2020

See all devices from Ningbo Ranor Medical Science & Technology Co., Ltd. →

• Are these blood pressure monitors intended for single-use or reusable applications, and how does that affect their clinical use?

  The Arm Blood Pressure Monitor comes in both single-use and reusable models (MJ1L, MJ2L vs. RN3L, RN4L, RN5L). Single-use models are designed for one-time clinical or home use, reducing infection risk in settings like hospitals or patient homes. Reusable models are meant for repeated use in clinical environments, requiring proper cleaning and maintenance between patients to ensure accuracy and hygiene. The manufacturer specifies storage and sterility guidelines per model to support safe reuse or disposal.

• What regulatory pathways have these devices followed, and how does that impact their use in clinical settings?

  The Arm Blood Pressure Monitor has undergone FDA 510(k) clearance through the Cardiovascular advisory committee, confirming it is *substantially equivalent* to a predicate device. This means it meets U.S. safety and performance standards for blood pressure measurement. Additionally, it complies with EU MDR regulations, ensuring its reliability for use in both clinical and home settings across regions where these approvals apply. The clearance type is traditional, indicating a thorough review process.

• How should these monitors be stored, and are there specific instructions for maintaining their accuracy and sterility?

  Storage requirements vary by model, but the manufacturer provides guidelines for each variant to ensure sterility and accuracy. Single-use models should be stored in a clean, dry environment away from direct sunlight or extreme temperatures until use. Reusable models require adherence to cleaning protocols between uses to prevent contamination and maintain calibration. Always refer to the manufacturer’s instructions for precise storage conditions, as improper handling could compromise readings or sterility.

• What types of environments are these devices suitable for, and do they differ in functionality between clinical and home use?

  These monitors are designed for both clinical settings (hospitals, doctor’s offices) and home use, with no inherent functional differences between the two environments. The reusable models (RN3L, RN4L, RN5L) are ideal for clinical use due to their durability and ease of maintenance, while single-use models (MJ1L, MJ2L) are practical for home monitoring or one-time clinical assessments. All models measure systolic, diastolic blood pressure, and pulse rate accurately, making them versatile for routine or periodic monitoring.