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Upper Arm Electronic Blood Pressure Monitor - U82D

FDA 510(k)

Class II (US FDA 510(k))

510(k) K243115

by Shenzhen Urion Technology Co., Ltd.

Identifiers

510(k) Number
K243115 FDA 510(k)
FDA Product Code
DXN FDA 510(k)
Models / Variants
including U80Y FDA 510(k)
U81Y FDA 510(k)
U82Y FDA 510(k)
U83Y FDA 510(k)
U86Y U80N FDA 510(k)
U81NH) FDA 510(k)
U86E series (including U82E FDA 510(k)
U80E FDA 510(k)
U80EH FDA 510(k)
U81E FDA 510(k)
U83E FDA 510(k)
U85E FDA 510(k)
U80L FDA 510(k)
U87E ) FDA 510(k)
U81X series (including U81X FDA 510(k)
U80X FDA 510(k)
U82X FDA 510(k)
U83X FDA 510(k)
U81D FDA 510(k)
U82D FDA 510(k)
U83D FDA 510(k)
U81RH FDA 510(k)
U82RH) FDA 510(k)
U83Z series (including U83Z FDA 510(k)
U80Z FDA 510(k)
U81Z FDA 510(k)
U82Z FDA 510(k)
U85Z FDA 510(k)
U86Z FDA 510(k)
U87Z)) FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1130 FDA 510(k)
Regulation Number
870.1130 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is an upper arm electronic blood pressure monitor, designed to measure systolic and diastolic blood pressure non-invasively. It falls under the category of automated sphygmomanometers, utilizing oscillometric technology to detect arterial pulsations and calculate blood pressure readings. The monitors are intended for clinical and home use to assess cardiovascular health and monitor hypertension. Each model in the series adheres to regulatory standards for accuracy and reliability in blood pressure measurement.

The monitors are supplied as reusable electronic devices, requiring calibration and maintenance as specified by the manufacturer. They are not sterile and are intended for use in clinical settings, such as hospitals, outpatient clinics, and home healthcare environments. The series includes multiple models with varying features, all of which have received FDA 510(k) clearance under the traditional pathway. Storage conditions and usage instructions must follow the manufacturer’s guidelines to ensure accurate and consistent performance.

Frequently asked questions

What is the U87Y series upper arm blood pressure monitor used for?

The U87Y series upper arm electronic blood pressure monitors are designed to measure systolic and diastolic blood pressure non-invasively. They utilize oscillometric technology to detect arterial pulsations and provide reliable readings for assessing cardiovascular health and monitoring hypertension. These devices are suitable for both clinical environments, such as hospitals and outpatient clinics, and home healthcare use.

Are the U87Y series monitors reusable or single-use?

The U87Y series upper arm blood pressure monitors are reusable electronic devices. They require regular calibration and maintenance as outlined by the manufacturer to ensure consistent accuracy and performance. Unlike single-use devices, these monitors are intended for repeated use in clinical and home settings, provided they are properly maintained and stored.

What models are included in the U87Y series?

The U87Y series includes multiple models across four sub-series: the U80Y, U81Y, U82Y, U83Y, and U86Y models; the U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, and U87E); the U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, and U82RH); and the U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z, and U87Z). Each model may feature slight variations in functionality or design but shares the same core purpose of measuring blood pressure.

How should the U87Y series monitors be stored?

To maintain accuracy and performance, the U87Y series monitors must be stored according to the manufacturer’s guidelines. This typically includes keeping the device in a clean, dry environment away from direct sunlight, extreme temperatures, and sources of electromagnetic interference. Proper storage ensures the device remains calibrated and functional for repeated use in clinical or home settings.

Are the U87Y series monitors sterile?

No, the U87Y series upper arm blood pressure monitors are not sterile. They are intended for clinical use but are not packaged or designed for sterile procedures. Users should follow standard hygiene practices, such as cleaning the cuff and device surfaces with appropriate disinfectants, to maintain a sanitary environment during use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Upper Arm Electronic Blood Pressure Monitor (U87Y series (models ..., PDF Regulation Manager Floor 4-6th of Building D, Jiale Science ..., Upper Arm Electronic Blood Pressure Monitor (U87Y series (models ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Urion Technology Co., Ltd.

Sources (1)

  • FDA 510(k) K243115 24 fields · synced Oct 5, 2026