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Arm Blood Pressure Monitor (MJ1D, MJ1DS, MJ3D, MJ5D, MJ6D, MJ8D, RN3D, MJ4D, RN1D, RN2D)

by Ningbo Ranor Medical Technology Co., Ltd.

510(k) K253142

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK253142 Date9 Jan 2026ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXN
Device Class
Class II
Regulation
21 CFR Part 870.1130
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Arm Blood Pressure Monitor is a noninvasive blood pressure measurement system that provides signals from which systolic, diastolic, and mean blood pressures can be derived through the use of transducers placed on the surface of the arm. This device is designed for accurate blood pressure monitoring in various clinical settings. The monitor is available in multiple models including MJ1D, MJ1DS, MJ3D, MJ5D, MJ6D, MJ8D, RN3D, MJ4D, RN1D, and RN2D.

The device is supplied by Ningbo Ranor Medical Technology Co., Ltd. and has received FDA 510(k) clearance with the regulation number 21 CFR 870.1130. It is classified under product code DXN and was reviewed by the Cardiovascular advisory committee. The device is intended for noninvasive blood pressure measurement and is not specified as single-use or reusable in the provided data.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Arm Blood Pressure Monitor used for?

    The Arm Blood Pressure Monitor is a noninvasive blood pressure measurement system that provides signals from which systolic, diastolic, and mean blood pressures can be derived. It is designed for accurate blood pressure monitoring in various clinical settings.

  • How is the Arm Blood Pressure Monitor supplied?

    The device is supplied by Ningbo Ranor Medical Technology Co., Ltd. with multiple models available including MJ1D, MJ1DS, MJ3D, MJ5D, MJ6D, MJ8D, RN3D, MJ4D, RN1D, and RN2D to meet different clinical needs.

  • What is the regulatory status of this device?

    The Arm Blood Pressure Monitor has received FDA 510(k) clearance with regulation number 21 CFR 870.1130. It is classified under product code DXN and was reviewed by the Cardiovascular advisory committee.

  • Is the Arm Blood Pressure Monitor single-use or reusable?

    The provided data does not specify whether the Arm Blood Pressure Monitor is single-use or reusable. The device is intended for noninvasive blood pressure measurement, but its reusability status is not indicated in the information provided.