Skip to content

Aneroid Sphygmomanometer BK2002

by Wenzhou Bokang Instrument Co., Ltd

510(k) K043286

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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K043286↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK043286 Date13 Jan 2005ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
Aneroid Sphygmomanometer, Model BK2002
510(k) Number
FDA Product Code
DXQ
FDA applicant
Wenzhou Bokang Instrument Co.,Ltd
Device Class
Class II
Regulation
21 CFR Part 870.1120
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.

The Aneroid Sphygmomanometer BK2002 is a blood pressure measurement device classified as an aneroid sphygmomanometer, designed to measure systolic and diastolic blood pressure non-invasively. It employs a mercury-free gauge with a zinc alloy casing to display pressure readings, eliminating the need for liquid-based measurement systems. This device is intended for clinical and home use to assess cardiovascular health by monitoring arterial blood pressure in adults and children.

The BK2002 is supplied as a reusable device, requiring periodic maintenance and calibration to ensure accuracy. It is not sterile and is intended for use in clinical settings, including hospitals, outpatient clinics, and home care environments. The device adheres to FDA 510(k) clearance (K043286) and MDR compliance, with an advisory committee classification under Cardiovascular (DXQ). Proper storage involves keeping the gauge dry and protected from physical damage to preserve functionality.

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.

  • Is this sphygmomanometer suitable for both clinical and home use, and if so, how does its design accommodate both environments?

    Yes, the Aneroid Sphygmomanometer BK2002 is explicitly designed for both clinical and home use to measure systolic and diastolic blood pressure non-invasively in adults and children. Its mercury-free zinc alloy casing ensures durability and reliability in professional settings like hospitals or clinics, while its reusable construction and non-sterile design make it practical for home monitoring. The device’s FDA 510(k) clearance and MDR compliance also support its use in regulated healthcare environments, though it is not sterile and requires periodic maintenance for accuracy.

  • How is the BK2002 different from traditional mercury-based sphygmomanometers, and what maintenance does it require?

    Unlike mercury-based sphygmomanometers, the BK2002 uses a mercury-free gauge with a zinc alloy casing, eliminating the risks associated with liquid mercury while maintaining accuracy. Since it is a reusable device, it requires periodic maintenance and calibration to ensure precise blood pressure readings over time. The manufacturer recommends keeping the gauge dry and protected from physical damage to preserve functionality, as outlined in its storage guidelines.

  • What storage conditions are necessary to keep the BK2002 in optimal working condition?

    To maintain the BK2002’s accuracy and longevity, it should be stored in a dry environment and protected from physical damage or impacts, which could compromise the gauge’s integrity. Since it is a reusable device, proper storage also helps prevent wear and tear between uses. The manufacturer does not specify temperature constraints, but avoiding extreme conditions is advisable to preserve the zinc alloy casing and overall functionality.

  • Is this device approved for use in children, and if so, what factors should clinicians consider when selecting the appropriate size?

    Yes, the BK2002 is designed for use in both adults and children, as stated in its description. However, the specific cuff sizes or models for pediatric use are not detailed in the provided data. Clinicians should ensure the cuff size matches the patient’s arm circumference for accurate readings, as improper sizing can lead to inaccurate blood pressure measurements. Since the device is reusable, compatibility with pediatric cuffs may require additional accessories not mentioned here.