# K040309: Digital Blood Pressure Monitor, Model DS-1862

- Pathway: 510(k) (Special)
- Applicant: Nihon Seimitsu Sokki Co., Ltd.
- Decided: Feb 24, 2004 after 15 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
Longest line of descent: 2 generations back to K850316 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993890: Digital Blood Pressure Monitor, Model DS-181, Nihon Seimitsu Sokki Co., Ltd. (1999) Summary page 1.

## Indications for use
For the noninvasive measurement of systolic and diastolic blood pressure and the determination of heart rate in adult patients, i.e. age 18 and above, in a homecare environment. Patients should be capable of understanding the instructions for use.

Source page: https://510kreport.com/device/K040309
Methodology: https://510kreport.com/methodology