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Automatic Digital Blood Pressure Monitor

by Aviche Shandong Medical Technology Co, Ltd.

510(k) K210152

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 NumberK210152 Date23 Sep 2021ClearedStatusActive

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 870.1130
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Automatic Digital Blood Pressure Monitor is a medical device designed to measure blood pressure levels. It functions by providing automated readings to assist in cardiovascular monitoring.

This device is supplied under FDA 510(k) clearance, identified by k-number K210152. It is intended for use in cardiovascular applications as specified in the regulatory filing.

Questions

AI-generated answers, 23 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 primary purpose of this blood pressure monitor?

    This device is designed to measure blood pressure levels automatically. It is intended for use in cardiovascular applications to assist clinicians and patients with cardiovascular monitoring.

  • What is the regulatory status of this device?

    The device is supplied under FDA 510(k) clearance, identified by k-number K210152. It was determined to be substantially equivalent to existing devices through a traditional submission process reviewed by the cardiovascular advisory committee.

  • Who is the manufacturer of this monitor?

    The monitor is manufactured by Aviche Shandong Medical Technology Co, Ltd., located in the High-Tech District of Jinan, China.