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Blood Pressure Monitor Smartlogic, Models KP-6210 and KP-6211

by K-jump Health Co., Ltd.

510(k) K022916

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 · Special NumberK022916 Date21 Nov 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  • Withdrawn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 Blood Pressure Monitor Smartlogic, Models KP-6210 and KP-6211, is an automated blood pressure monitoring device designed to measure systolic, diastolic blood pressure, and pulse rate. It utilises an inflating cuff to obtain these readings, adhering to the functional definition of a non-invasive blood pressure monitor.

These devices are intended for use in clinical and home settings, supplied as reusable equipment. They have been granted FDA 510(k) clearance under Special Review by the Cardiovascular Advisory Committee, with a product code of DXN. The models KP-6210 and KP-6211 share the same intended use and technology as the previously cleared model KP-6120.

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