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Reusable NIBP Cuff

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K191253

by Shenzhen Changke Connect Electronics Co., Ltd.

Identifiers

510(k) Number
K191253 FDA 510(k)
FDA Product Code
DXQ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1120 FDA 510(k)
Regulation Number
870.1120 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Reusable NIBP Cuff is a non-invasive blood pressure measurement device designed for repeated clinical use. Classified under 21 CFR 870.1120 as a blood pressure cuff, it is intended for measuring systolic and diastolic blood pressure in adult patients via oscillometric technology.

This cuff is constructed from nylon material and features a single-tube design for durability and ease of use. Supplied in multiple sizes (25–35 cm), it is intended for reusable application in hospital, clinical, or home settings. Authorized under FDA 510(k) clearance (K191253) and MDR compliance, it adheres to regulatory standards for cardiovascular monitoring devices.

Frequently asked questions

What types of patients is this cuff designed for, and how does its size range accommodate different users?

This cuff is specifically designed for measuring blood pressure in adult patients using oscillometric technology. The size range of 25–35 cm ensures compatibility with a broad range of arm circumferences, making it suitable for most adult patients in hospital, clinical, or home settings. The nylon construction and single-tube design enhance durability, allowing repeated use across diverse patient populations.

Is this cuff intended for single-use or repeated clinical use, and what materials is it made from?

The cuff is explicitly designed for reusable clinical use, as stated in the description. It is constructed from nylon material, which contributes to its durability and longevity, making it suitable for repeated applications in healthcare environments.

What regulatory pathways has this device undergone, and which committees were involved in its review?

This cuff has been authorized through FDA 510(k) clearance (K191253) and MDR compliance, demonstrating adherence to regulatory standards for cardiovascular monitoring devices. The review was conducted under the Cardiovascular (CV) Advisory Committee and classified under 21 CFR 870.1120 as a blood pressure cuff, with a decision described as *Substantially Equivalent*.

How is the cuff supplied, and what settings is it intended for?

The cuff is supplied in multiple sizes (25–35 cm) to accommodate different adult patients. It is intended for use in hospital, clinical, or home settings, where repeated blood pressure measurements are required. The reusable design and nylon construction make it practical for continuous use in these environments.

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: Reusable NIBP Cuff (K191253) — FDA 510 (k) | Innolitics, NIBP Cuff_Changke Connect, Changke Connect

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Changke Connect Electronics Co., Ltd.

Sources (2)

  • FDA 510(k) K191253 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026