# K043531: Modification to Arm Blood Pressure Monitor, Models KP-6821, KP-6822

- Pathway: 510(k) (Special)
- Applicant: K-Jump Health Co., Ltd.
- Decided: Apr 21, 2005 after 121 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) K-jump Health Co., Ltd. Arm Blood Pressure Monitor Models KP-6821, KP-6822: named in the summary without a submission number

## Indications for use
The Arm BPM is intended to measure the systolic, diastolic, and pulse rate (heart rate) by using an inflating cuff which is wrapped around the upper arm. The device is indicated for use in adults.

Source page: https://510kreport.com/device/K043531
Methodology: https://510kreport.com/methodology