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Wristwatch BPM Blood Pressure Monitor, Model KP-6120

by K-jump Health Co., Ltd.

510(k) K002665

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 NumberK002665 Date19 Mar 2001ClearedStatusActive

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  • Withdrawn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 Wristwatch BPM Blood Pressure Monitor, Model KP-6120, is a noninvasive blood pressure measurement system classified under § 870.1130. It is designed to provide readings for systolic, diastolic, and mean arterial pressure by utilizing transducers placed on the wrist, enabling continuous or intermittent monitoring of blood pressure.

This device is intended for single-use or reusable applications in clinical or home settings, depending on manufacturer guidelines. It has received FDA 510(k) clearance under K002665, classified as substantially equivalent to predicate devices. The monitor is intended for use in environments where accurate blood pressure assessment is required, adhering to regulatory standards for noninvasive measurement systems.

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