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Arm Blood Pressure Monitor, Models KP-6821, KP-6822

by K-jump Health Co., Ltd.

510(k) K014204

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 NumberK014204 Date5 Mar 2002ClearedStatusActive

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  • Withdrawn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, 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 Arm Blood Pressure Monitor, Models KP-6821 and KP-6822, is an arm-based blood pressure measurement device designed to assess systolic, diastolic, and pulse rate. It incorporates an inflatable cuff wrapped around the upper arm and a semiconductor sensor to detect pressure oscillations, providing accurate readings for adult users.

This device is operated manually via integrated keys and features an internal air pump for cuff inflation. Supplied as a reusable device, it is intended for clinical and home use. The monitor displays measurements on an LCD screen and has received FDA 510(k) clearance under product code DXN, with a decision date of March 5, 2002.

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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.

  • What types of blood pressure readings does this device measure, and how does it determine them?

    This arm-based blood pressure monitor measures systolic, diastolic, and pulse rate. It uses an inflatable cuff wrapped around the upper arm and a semiconductor sensor to detect pressure oscillations, which it translates into accurate readings for adult users. The device inflates the cuff automatically via an internal air pump and displays results on an LCD screen.

  • Is this device intended for single-use or reusable applications, and how does that affect its maintenance?

    The device is designed for reusable clinical and home use. Since it is not single-use, proper maintenance—such as cleaning the cuff and screen between uses—is required to ensure accuracy and hygiene. The manufacturer’s instructions should be followed to avoid damage or contamination.

  • What are the key differences between the KP-6821 and KP-6822 models, if any?

    The provided data does not specify technical or functional differences between the KP-6821 and KP-6822 models. Both are described as arm-based blood pressure monitors with identical features (systolic/diastolic/pulse measurement, LCD display, and manual operation). Clarification on model-specific variations would require consulting the manufacturer’s documentation.

  • How was this device’s regulatory pathway determined, and which committee reviewed its submission?

    This device followed a traditional 510(k) pathway and was deemed substantially equivalent to a predicate device. Its submission was reviewed by the FDA’s Cardiovascular (CV) Advisory Committee before clearance under product code DXN. The decision was finalized on March 5, 2002.