2120 Non-Invasive Blood Pressure Monitor W/Cuff

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

510(k) Number

K861987 ↗

FDA Product Code

DXN

Device Class

Class II

Regulation

21 CFR Part 870.1130

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What is the 2120 Non-Invasive Blood Pressure Monitor designed for?

  The 2120 Non-Invasive Blood Pressure Monitor is designed for measuring arterial blood pressure non-invasively in patients of all ages. It uses oscillometric technology to provide accurate systolic and diastolic readings by inflating and deflating a cuff around the upper arm or wrist. This makes it suitable for clinical settings like hospitals, outpatient clinics, and home healthcare environments where reliable blood pressure monitoring is required.

• Is the 2120 Non-Invasive Blood Pressure Monitor single-use or reusable?

  The 2120 Non-Invasive Blood Pressure Monitor is a reusable system. It is not designated as single-use, so proper cleaning and maintenance are required to prevent contamination and ensure device accuracy and longevity. Regular calibration is also necessary to maintain performance standards.

• How is the device supplied, and what maintenance is required?

  The device is supplied as a reusable system, including a cuff for upper arm or wrist use. To maintain accuracy and hygiene, it requires periodic cleaning, calibration, and adherence to manufacturer guidelines. These steps are essential for preventing contamination and ensuring the device operates within regulatory compliance for non-invasive blood pressure measurement.

• What regulatory approval does the 2120 Non-Invasive Blood Pressure Monitor hold?

  The 2120 Non-Invasive Blood Pressure Monitor holds FDA 510(k) clearance under the reference number K861987. This clearance is based on a determination of substantial equivalence to a predicate device, meeting traditional regulatory requirements for Class II devices under the Special Controls for Non-Invasive Blood Pressure Measurement Systems (21 CFR 870.1130).

• Can this monitor be used for wrist measurements?

  Yes, the 2120 Non-Invasive Blood Pressure Monitor is designed to accommodate both upper arm and wrist cuffs, allowing flexibility in measurement locations. The oscillometric technology ensures accurate readings regardless of the cuff placement, making it versatile for different patient needs and preferences.