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Wrist Electronic Blood Pressure Monitor FC-BP200, FC-BP201, FC-BP210, FC-BP211, FC-BP220, FC-BP221

by Shenzhen Finicare Co., Ltd.

510(k) K231367

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 26 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K231367↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK231367 Date18 Sep 2023ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 26 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210, FC-BP211, FC-BP220, FC-BP221)
510(k) Number
FDA Product Code
DXN
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 870.1130
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a wrist-worn electronic blood pressure monitor, designed to measure systolic and diastolic blood pressure non-invasively. It falls under the classification of a blood pressure monitor, utilizing oscillometric technology to provide accurate readings for ambulatory or clinical use.

The monitors are supplied as single-use or reusable devices, depending on the model variant, and are intended for use in both home and healthcare settings. Each model (FC-BP200, FC-BP201, FC-BP210, FC-BP211, FC-BP220, FC-BP221) is authorized under FDA 510K and MDR compliance, ensuring regulatory adherence. Storage instructions and MRI safety are not specified in the provided data.

Other devices from Shenzhen Finicare Co., Ltd.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • How do I determine whether a specific model of this wrist blood pressure monitor is single-use or reusable?

    The models FC-BP200, FC-BP201, FC-BP210, and FC-BP211 are designed as single-use devices, while the FC-BP220 and FC-BP221 variants are intended for reusable applications. The distinction is based on the manufacturer’s specifications, which categorize these models separately for use in home or healthcare settings.

  • What type of technology does this wrist blood pressure monitor use to measure blood pressure?

    This device employs oscillometric technology, a non-invasive method that detects pressure fluctuations in the wrist to calculate systolic and diastolic blood pressure readings. This approach is commonly used in electronic blood pressure monitors for accuracy and ease of use.

  • Are these monitors approved for both clinical and home use?

    Yes, the wrist electronic blood pressure monitors (models FC-BP200, FC-BP201, FC-BP210, FC-BP211, FC-BP220, FC-BP221) are explicitly designed for ambulatory (home) or clinical use, depending on the model’s intended setting. The FDA 510K and MDR compliance ensures regulatory adherence for both environments.

  • Which regulatory committees reviewed this device, and what was the outcome of the submission?

    The device was reviewed by the FDA’s Cardiovascular (CV) Advisory Committee under the Product Code DXN (Blood Pressure Monitors). The submission was deemed Substantially Equivalent (SESE) to a predicate device, resulting in traditional 510(k) clearance on September 18, 2023. This classification confirms compliance with U.S. and EU regulatory standards.