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Upper Arm Electronic Blood Pressure Monitor - FC-BP101

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K220113

by Shenzhen Finicare Co., Ltd.

Identifiers

510(k) Number
K220113 FDA 510(k)
FDA Product Code
DXN FDA 510(k)
Models / Variants
Model FC-BP100 FDA 510(k)EUDAMED
FC-BP101 FDA 510(k)EUDAMED
FC-BP102 FDA 510(k)EUDAMED
FC-BP110 FDA 510(k)EUDAMED
FC-BP111 FDA 510(k)EUDAMED
FC-BP112 FDA 510(k)EUDAMED

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)

The Upper Arm Electronic Blood Pressure Monitor (Models FC-BP100, FC-BP101, FC-BP102, FC-BP110, FC-BP111, FC-BP112) is a non-invasive electronic device designed to measure systolic and diastolic blood pressure via oscillometric principles. It is classified under the nomenclature for blood pressure monitors and operates by inflating a cuff around the upper arm to temporarily occlude arterial flow, then detecting pressure fluctuations to calculate blood pressure readings.

This device is intended for single-use or reusable clinical and home settings, depending on the model variant, and requires no special sterility conditions beyond standard hygiene practices. The monitors are approved under FDA 510K and MDR regulations, with models distinguished by their specific reference codes. Storage should follow manufacturer guidelines to preserve functionality, and compatibility with MRI environments is not specified.

Frequently asked questions

Are these monitors intended for single-use or reusable clinical settings, and how should they be handled between uses?

The Upper Arm Electronic Blood Pressure Monitors (Models FC-BP100, FC-BP101, FC-BP102, FC-BP110, FC-BP111, FC-BP112) are designed for both single-use and reusable clinical or home settings, depending on the specific model variant. Since the device does not require special sterility conditions beyond standard hygiene practices, reusable models should be cleaned and disinfected according to the manufacturer’s instructions to maintain functionality and prevent cross-contamination. Always follow the manufacturer’s guidelines for proper handling and maintenance.

How do I determine which model variant is best suited for my clinical or home use, and are there differences in functionality?

The models (FC-BP100, FC-BP101, FC-BP102, FC-BP110, FC-BP111, FC-BP112) are differentiated by their specific reference codes, but the device data does not specify functional distinctions between them beyond the general design for upper-arm blood pressure measurement. The key difference likely lies in single-use vs. reusable design or additional features not detailed here. For precise selection, consult the manufacturer’s documentation or contact Shenzhen Finicare Co., Ltd. to confirm compatibility with your intended use case.

What storage conditions should I follow to ensure the monitors remain functional over time?

While the device data does not provide explicit storage specifications, standard best practices for electronic blood pressure monitors—such as keeping them in a dry, clean environment away from extreme temperatures or direct sunlight—should be followed. Always refer to the manufacturer’s instructions for model-specific storage guidelines to preserve functionality and accuracy. Avoid exposure to moisture or physical damage.

What regulatory pathways have these monitors undergone, and how does that affect their use in clinical settings?

The Upper Arm Electronic Blood Pressure Monitors have been cleared under FDA 510K (K220113) and comply with MDR (Medical Device Regulation) requirements. This means they meet U.S. and EU regulatory standards for safety and performance, but their use in clinical settings is still subject to facility-specific protocols, such as infection control policies. The clearance does not imply any specific clinical indication—only that the device is suitable for measuring systolic and diastolic blood pressure via oscillometric principles in approved settings.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Finicare Co., Ltd.

Sources (2)

  • FDA 510(k) K220113 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026