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Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff

FDA 510(k)

Class II (US FDA 510(k))

510(k) K182433

by Shenzhen Caremed Medical Technology Co., Ltd.

Identifiers

510(k) Number
K182433 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)

This device is a blood pressure cuff, available in both reusable and disposable configurations. It is designed for non-invasive blood pressure monitoring and is compatible with major patient monitoring systems.

The cuff is supplied in various sizes, ranging from adult thigh to neonate 5#, and features single or double tube designs with specific connectors for use with monitors from brands such as Philips, Siemens, GE, Nihon Kohden, and Mindray. It is authorized under FDA 510(k) clearance (K182433) and is intended for use in clinical settings where non-invasive blood pressure measurement is required.

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: Caremed Medical, FDA and CE Approved Leading Medical Accessories ..., Shenzhen Caremed Medical Technology Co., Ltd, Caremed Reusable Blood Pressure Cuffs - Reliable & Durable

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Caremed Medical Technology Co., Ltd.

Sources (1)

  • FDA 510(k) K182433 24 fields · synced Sep 25, 2026