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Digital Blood Pressure Monitor (Model: YB-800)

by Wenzhou Yosun Medical Technology Co., Ltd.

510(k) K231478

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK231478 Date15 Dec 2023ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXN
FDA applicant
Wenzhou Yosun Medical Technology Co.,Ltd
Device Class
Class II
Regulation
21 CFR Part 870.1130
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

A Digital Blood Pressure Monitor is a device intended to measure systolic and diastolic blood pressure, as well as pulse rate, in adults via non-invasive oscillometric technique. It consists of a main unit containing a CPU, pressure sensor, air pump, solenoid valve, uniform speed vent valve, PCB, and LCD, along with an inflatable arm cuff.

The device is supplied with an inflatable cuff sized for arm circumferences of 22-32 cm. It is intended for use in clinical or home settings to assess cardiovascular parameters. The device received FDA 510(k) clearance (K231478) as a Class II device under product code DXN, with a traditional clearance pathway and a decision of substantially equivalent to a predicate device.

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Questions

AI-generated answers, 25 Sep 2026

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

  • What is the Digital Blood Pressure Monitor YB-800 used for?

    It measures systolic and diastolic blood pressure and pulse rate in adults using non-invasive oscillometric technique, intended for cardiovascular assessment in home or clinical settings.

  • What size arm cuff is included with the YB-800 monitor?

    The device is supplied with an inflatable cuff designed for arm circumferences ranging from 22 to 32 cm, ensuring proper fit for a wide range of adult users.

  • Is the YB-800 blood pressure monitor reusable or single-use?

    The monitor is a reusable electronic device; only the inflatable cuff may require replacement over time due to wear, but the main unit is designed for repeated use with proper maintenance.

  • How was the YB-800 cleared for market release?

    It received FDA 510(k) clearance (K231478) as a Class II device under product code DXN, determined to be substantially equivalent to a predicate device via the traditional review pathway.